Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017


August 29, 2017 OrthoSpineNews

August 28, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the appointment of Steven Chartier as Vice President of Regulatory and Clinical Affairs. Mr. Chartier brings more than 25 years of operational expertise leading global regulatory strategy, especially in the Asia Pacific markets, and clinical development for emerging and established companies in the medical technology and biotechnology industries. In his new role at Anika, Mr. Chartier will be responsible for overseeing and directing the clinical development course for the Company’s orthobiologics and regenerative medicine pipeline and advancing promising candidates like CINGAL® and HYALOFAST® through U.S. and ex-U.S. regulatory channels.

“We’re excited to strengthen and solidify our regulatory and clinical development capabilities with the addition of Mr. Chartier, a veteran regulatory and clinical affairs professional with proven expertise in spearheading regulatory strategy and leading a wide array of products through U.S. and global approvals,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “Mr. Chartier is the latest of the strategic, senior-level hires we’ve made to advance our robust orthobiologics and regenerative medicine pipeline, and build out our direct commercialization capabilities that will bring forth the next decade of growth for Anika.”

Most recently, Mr. Chartier served as Vice President of Regulatory Affairs and Quality Assurance at Augmenix, Inc., a growth-oriented, privately-held medical device company focused on improving the outcomes of radiotherapy through the use of absorbable hydrogels. Prior to his time at Augmenix, Mr. Chartier served as Chief Operations Officer at PixarBio Corporation and Chief Operating Officer at Infraredx, Inc., where he developed broad operational prowess and led U.S. and global regulatory, quality and clinical development strategy for these entrepreneurial organizations. Mr. Chartier also held positions at Biogen, Inc., a large public company opportunity where he honed his clinical development skills, and at Nucryst Pharmaceuticals, where he spent almost a decade building and maintaining the regulatory and quality functions to support worldwide approval and compliance of regulated medical device and pharmaceutical products.

“Anika’s expansive commercial portfolio and global footprint are impressive, and I see tremendous potential in its diversified product pipeline that lends itself to a steady flow of regulatory filings and approvals in the U.S. and overseas,” said Steven Chartier, Vice President of Regulatory and Clinical Affairs at Anika Therapeutics. “I believe my experience working with Asia Pacific regulatory authorities will be especially valuable to Anika, as this region represents a tremendous growth opportunity for the orthopedic medicine market.”

Mr. Chartier launched his career in clinical research and clinical trial coordination at Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. Mr. Chartier received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society in 2003, and he holds a Bachelor of Arts in Psychology from Saint Anselm College. Click HERE to view Mr. Chartier’s full bio.

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 cartilage 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:
Pure Communications
Sonal Vasudev, 917-523-1418,


August 29, 2017 OrthoSpineNews

August 29, 2017

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics, a medical device company that develops and manufactures cutting-edge joint replacement implants and approaches, today announced the launch of its Procotyl® Prime Acetabular Cup System.

“At MicroPort Orthopedics, we embrace the constant advance in orthopedic medicine, and have a deep commitment to creating products that make patients’ lives better,” said Aurelio Sahagun, President. “The Procotyl® Prime Acetabular Cup System, with its best-in-class features, is a great example of this commitment, as it not only strengthens our position as a leader in surgical joint replacement, but also complements our existing products and surgical approaches to help patients return to full function faster.”

The Procotyl® Prime Acetabular Cup System, which is the next step in the evolution of the successful Dynasty® Acetabular Cup System, received 510k Clearance from the U.S. Food & Drug Administration in late June.

“Procotyl® Prime’s design is a culmination of over 20 years of market experience coupled with intelligent design and engineering,” said Dr. James Chow, Director of Orthopedics Hip & Joint at Phoenix St. Luke’s Medical Center. “We set out to design an implant optimized for highly-crosslinked polyethylene and modern 3D fixation surfaces, allowing us to eliminate compromises. The result is a shell that is strong and flexible, has maximized poly thickness and robust pull-out strength, all while allowing the versatility of large head options in the smallest sizes.”

In addition to the benefits of the implant, the Procotyl® Prime system is the first on the market designed with simple, versatile instrumentation to support a variety of surgical approaches, including all of MicroPort’s soft-tissue sparing philosophies.

Dr. Brad Penenberg, Chief of Arthroplasty Service at Cedars-Sinai Hospital, said, “Procotyl® Prime is the first acetabular component adapted for MicroPort’s novel portal-assisted acetabular instrumentation. This unique approach facilitates preservation of soft tissue, fast patient recovery, and direct acetabular visualization.”

For more information about the Procotyl® Prime Acetabular Cup System or MicroPort Orthopedics, visit or follow the brand on Twitter and Facebook.

About MicroPort Orthopedics
Established in January 2014, MicroPort Orthopedics Inc. is the fifth largest multinational producer of hip and knee implants and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative OrthoRecon products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japanese, Latin American and China markets. For more information about MicroPort Orthopedics, visit

About MicroPort Scientific
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to:

Forward-Looking Statements
Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

All rights reserved.

Copyright © 2017 MicroPort Scientific Corporation


Sharon Correia


August 28, 2017 OrthoSpineNews

28 Aug 2017

Allegra Orthopaedics Ltd (ASX:AMT) is continuing to make significant progress with its unique bone substitute technology “Sr-HT-Gahnite” and is aiming to progress into the production phase.

The company is an orthopaedic manufacturer and has obtained the global license to the composite biocompatible ceramic material known as Sr-HT- Gahnite from the University of Sydney.

Allegra’s tests have indicated that all the samples containing the Sr-HT Gahnite scaffolds showed promising ingrowth of bone through the scaffold and in some cases completely bridged the defect.

Importantly, there was no evidence of inflammation or formation of fibrous tissue, indicating good biocompatibility of the Sr-HT Gahnite.

The company is also studying the various commercial applications of this unique bone substitute technology, before commencing with interbody cervical spinal cages as the initial product offering.




August 28, 2017 OrthoSpineNews

SILVER SPRING, Md.Aug. 28, 2017 /PRNewswire-USNewswire/ — One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.

However, with all of the medical potential, also comes novelty and uncertainty as this field matures. There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products. These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients. These so-called treatments run afoul of the FDA’s legal and regulatory framework governing this new field.

At the same time, it’s incumbent upon the FDA to make sure that this existing framework is properly defined, with bright lines separating new treatments that are medical products subject to the FDA’s regulation from those therapies that are individualized by surgeons in such a way that they are not subject to FDA regulation. The field of regenerative medicine, because of the very nature of the science and the rapidly evolving clinical developments, not infrequently lends itself to often close calls between what constitutes an individualized treatment being performed by a doctor within the scope of his medical practice on the one hand, and what constitutes a medical product that is currently subject to the authorities Congress has already charged the FDA with exercising.

For example, sometimes when cells or tissues are taken from and given back to the same individual or when the cells or tissues do not undergo significant manufacturing, are intended to perform the same basic functions, and are not combined with another drug or device, among other factors; their benefits and risks are well understood. In these circumstances, the products may not require premarket review under current law. However, when significant manufacturing is performed on the cells or tissues, or when the cells or tissues are not intended to perform the same basic functions, far greater uncertainty exists as to the benefits and risks involved. In these cases, it’s necessary to understand the benefits and risks in clinical trials prior to widespread use of the products. Therefore, premarket review is required.

At the same time that we take steps to prevent unscrupulous actors from being able to deceive patients and potentially harm their health, we also need to make sure that the vast majority of responsible product developers know where the regulatory lines governing this new field are drawn. The FDA must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation.

To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area. At the same time, this fall the FDA will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. This comprehensive policy is based on our existing authority. It will offer responsible product developers – including individual providers working in clinics and academic hospitals and advancing their own products as part of regenerative medicine procedures – a way to more efficiently gain FDA approval for their products through a process that is minimally burdensome and less costly. Many of the individualized treatments fall clearly outside the FDA’s pre-market requirements. For those that currently fall across the line and are subject to the FDA’s existing pre-market review, we want to make sure the process for gaining FDA approval is efficient. We want to facilitate innovation. We seek a regulatory process that accommodates the complexity of developing these therapies, and takes measure of their tremendous and near-term potential.

Stepped Up Enforcement

In terms of compliance, and with regard to our increased oversight and enforcement: In the last few days alone, the FDA has taken steps in Florida and California to address a number of especially troubling products being marketed. But unfortunately, these are examples of a larger pool of actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they create a potential danger to patients. We have examples where some of these unproven treatments have clearly harmed patients.

As the agency responsible for ensuring these therapies are safe and effective, I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health. Late last week, FDA worked with the United StatesAttorney to ask a court to seize the components of a product that involved the use of vaccinia virus vaccine as part of a purported treatment for cancer that FDA believes created the potential for substantial risks to patients. The product posed significant public health concerns for the agency.

Efficient Regulation

With regard to our regulation of these products, I want to expand on the need for bright lines and appropriate oversight to accommodate the good actors working on genuine science.

As we work to protect Americans from the bad actors, I’m equally committed to doing all we can to help bring to patients more quickly innovative, scientifically proven regenerative cell therapies. For this reason, we’re developing a comprehensive and efficient, science-based policy with the aim of accelerating the proper development of these products.

The FDA will advance the new framework this fall. This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency’s current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness. The policies will be set forth in a series of guidance documents that are the result of a public process we have held in recent years. The new policy will build upon the agency’s current risk-based, flexible regulatory framework. It will also serve to implement provisions of the 21st Century Cures Act related to regenerative medicine. The FDA has already held public meetings to inform its thinking in these areas, so much of the agency’s approach is already part of the public record. We’ll continue to work with industry and the scientific community to perfect the process for bringing safe and effective treatments to patients.

At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval. And we will also be developing a novel approach to FDA approval that we believe will allow very small product developers to gain all the benefits of FDA approval through a process that is minimally burdensome and less costly. We’re mindful of the significant promise offered by regenerative medicine, the cost of innovation in this industry, the small companies engaging in these enterprises, and the difficulty of doing FDA registration trials in this field. Our framework will take measure of all of these challenges.

In addition, the FDA will continue to work closely with industry to find other ways to aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible. One of these will include our continued commitment to fully implement the Regenerative Medicine Advanced Therapy (RMAT) designation. This pathway enables regenerative cell therapies to access the FDA’s existing expedited programs to help foster the development and approval of these novel products. Among other things, we plan to include certain gene therapy products that permanently alter tissue and produce a sustained therapeutic benefit as part of the products that will meet the definition of being eligible to come under the pathway enabled by RMAT. This is part of our broader commitment to pursue efforts that will advance innovation in this space. We encourage sponsors who are seeking FDA approval of their product to consider this pathway.

Ultimately, the agency’s goal is to make sure that the potential of regenerative medicine can continue to advance to benefit the patients who need new and innovative options for their medical problems. These technologies hold out the potential to significantly alter the course of a broad range of diseases. We are committed to taking steps to make sure these opportunities advance as quickly as possible. To do so, we must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit. We will also continue to take steps to keep those who would exploit this promising area from harming patients and abusing the public’s trust. We can’t let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.

For more information:

FDA warns US Stem Cell Clinic of significant deviations

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients


Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products

Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Lyndsay Meyer, 240-402-5345,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


August 28, 2017 OrthoSpineNews

OR AKIVA, Israel and PRINCETON, New JerseyAugust 28, 2017 /PRNewswire/ —

Regentis Biomaterials Ltd., a privately held company developing proprietary hydrogels for tissue regeneration, announced today it has received European CE mark approval for its GelrinC® biodegradable implant. The approval covers GelrinC manufactured using denatured human fibrinogen and expands upon the existing CE mark for a version containing denatured bovine-sourced fibrinogen. This latest approval enables Regentis to begin accessing new global markets, and helping more patients suffering from damaged articular knee cartilage.

“Since a CE mark is recognized internationally, this key approval opens the door to making the product available in many other territories,” said Regentis Biomaterial CEO Alastair Clemow, Ph.D.

GelrinC is designed to quickly and easily treat articular knee cartilage defects, both chondral and osteochondral. With a minimally invasive procedure, surgeons apply GelrinC into lesions as a liquid allowing it to fill any size and shape of defect. After a short exposure to ultra-violet light, GelrinC is converted into a solid implant which gradually degrades in a controlled manner. Over time, the implant is replaced with newly formed cartilage tissue that is similar to native cartilage, and fits within the surrounding cartilage and underlying bone.

A long-term European clinical study of GelrinC, focusing on patients with damaged articular knee cartilage, demonstrated sustained relief of symptoms with most patients regaining pain-free knees. MRI imaging further revealed that the regenerated cartilage had properties that were comparable to natural cartilage. Regentis is currently conducting an FDA-approved Phase III pivotal multi-site clinical trial on GelrinC in the U.S. and Europe to support a PMA application, a key step to having the product approved for patients in the U.S.

“The data from our European clinical study indicates that GelrinC provides surgeons with an effective one-step treatment. GelrinC is an off-the-shelf product that can be used at any time during surgery when a lesion is identified without the need for pre-planning or additional surgeries,” said Dr. Clemow. “This makes GelrinC an attractive treatment option that is as simple to perform as microfracture with superior clinical outcomes. With a potential yearly market of more than 150,000 procedures in the U.S. alone, the opportunities for GelrinC as the primary treatment for articular knee cartilage repair are very exciting.”

GelrinC is an investigational device and not available for sale in the U.S.

About Regentis Biomaterials
With offices in Israel and the U.S., Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration.  The company’s core technology platform is based on a series of hydrogels utilizing both polyethylene glycol diacrylate and denatured fibrinogen that combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance. This technology serves as the foundation for future clinical indications in osteoarthritis.  The company’s flagship product, GelrinC® is designed for the treatment of articular cartilage lesions.  For more information, please visit

For more information, please contact:
Alastair Clemow, Ph.D., President & CEO
Tel: +1-508-930-8865

For media inquiries, please contact:
Josh Turner
Tel: +972-54-949-6526
SOURCE Regentis Biomaterials Ltd.


August 28, 2017 OrthoSpineNews

Schlieren (Zurich), Switzerland, August 28, 2017 – Kuros Biosciences announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Putty indicated for use as an autograft extender in posterolateral spine. This market clearance allows commercialization of MagnetOs Putty in the United States and complements the existing clearance for MagnetOs Granules, which was granted by the FDA in February 2017. In addition, Kuros has filed MagnetOs Putty for CE mark certification in Europe. MagnetOs is a novel synthetic bone graft substitute designed to regenerate bone in the implanted site in the body. Numerous studies have shown that MagnetOs leads to progressive bone formation and implant resorption comparable to current gold standard autograft.

Ivan Cohan-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us and supports our commitment to develop and launch innovative products that meet the demands of surgeons, their patients and the payers.” He continued: “MagnetOs Putty has now been cleared or submitted in our main target markets, which is key for our strategy to build a leading orthobiologics company. It is also a testimony to our Group’s science, development capabilities and teamwork. We now look forward to rolling out our commercialization activities.”

Under the terms of the combination agreement with Xpand Biotechnology B.V., the clearance for MagnetOs Putty in the United States triggers the issue of another 0.37 million shares from Kuros’ authorized share capital to the former owners of Xpand Biotechnology B.V.

MagnetOs promotes local bone formation equivalent to current gold standard autograft

MagnetOs is a synthetic 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 autograft (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and risks associated with its harvesting from another healthy site of the patient’s body). MagnetOs is based on calcium phosphate with a novel and unique surface structure that greatly enhances its ability to promote local bone formation. The product is available as granules and as a putty formulation.

For further information, please contact:

Kuros Biosciences AG

Harry Welten

Chief Financial Officer

Phone +41 79 750 15 64


About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit 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.


August 25, 2017 OrthoSpineNews

Aug 24, 2017 – Charlie Taylor

Dublin-listed Mainstay Medical, a company that is targeting chronic back pain with an implantable device, is expecting to seek further funding in the near future as it ramps up its commercialisation plans.

The medical devices firm, which recently announced it had passed the mid-point in clinical trials in the US, made its first commercial sale earlier this year in Germany.

Mainstay’s ReActiv8 product is implanted in a surgical procedure and works by using electrical stimulus of nerves in muscles supporting the lower spine. The product won European approval last year after which it raised €30 million in funding to commercialise ReActiv8.

Speaking to The Irish Times, chief executive Peter Crosby said it was looking at various options in terms of additional fundraising.

“We know we will need more capital to complete the US trial and to get pre-market approval. We’ll also need more to drive commercialisation, but we haven’t given any indication yet on how much we’ll be looking for or when,” said Mr. Crosby.



August 24, 2017 OrthoSpineNews

WARSAW, Ind.Aug. 24, 2017 /PRNewswire/ — Today, DePuy Synthes* announces an exclusive U.S. agreement with JointPoint, Inc. to co-market its proprietary software platform to provide an easy-to-use, surgeon-friendly navigation system that can help deliver improvements in surgical outcomes. JointPoint’s software provides non-invasive computer navigation, pre-surgical digital templating, case planning, and feedback while performing total hip replacement surgeries. JointPoint easily integrates with the Anterior Approach. The Anterior Approach is a minimally invasive surgical approach that allows a surgeon to work around the muscles, rather than cut through them, to get to the hip joint.

Adding the JointPoint software to a surgeon’s protocol may help reduce leg length discrepancy and complications related to inaccurate cup placement and final implant selection – two of the most important considerations in hip replacement surgery – by providing pre-surgical digital templating and real-time, data-driven surgical decision making in the operating room.

“We are thrilled to partner with JointPoint to help provide more predictive outcomes for surgeons and their patients,” said Aaron Villaruz, Global Hip Platform Leader, DePuy Synthes Joint Reconstruction. “By providing access to important information at key stages of the hip replacement process, together we can help surgeons streamline cases and allow for pre-surgical goals to be achieved more consistently.”

One of the important features of the JointPoint software is OneTrial™, which can predict optimal implant combinations based on pre-surgical goals using just two images during surgery. Unique to DePuy Synthes implants is the ability of OneTrial™ to also provide precise recommendations on implant size and position to enable more confident adjustments and reduce OR time and fluoroscopy by eliminating re-trialing. Additionally, the JointPoint software helps streamline communications through a JointPoint calendar, case sharing, and case planning/collaboration.

“During hip replacement surgery, physicians strive for optimal implant choices and positioning to improve patient satisfaction by achieving proper leg length, offset, and cup positioning. JointPoint Hip Navigation System gives surgeons the confidence with real time feedback so they can ultimately help restore patients back to their natural function efficiently while minimizing fluoroscopy,” said Dr. Andrew J. Cooper**, MD. “I’m excited about what JointPoint can offer those surgeons whose patients are good candidates for the Anterior Approach.”

DePuy Synthes will begin co-marketing the JointPoint software in the second half of 2017.

About DePuy Synthes Companies

DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies 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

About JointPoint, Inc.

JointPoint, Inc. develops and markets software-driven medical technology for orthopaedics. The JointPoint software solution and OneTrial™ technology is a completely non-invasive navigation system for hip replacement surgery that provides intraoperative data and guides component selection while also optimizing efficiency within a surgical workflow. For more information, visit

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**Consultant to DePuy Synthes Joint Reconstruction with an ownership interest in JointPoint, Inc.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

Photo courtesy of JointPoint, Inc.

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


SOURCE DePuy Synthes

Related Links


August 24, 2017 OrthoSpineNews

SALISBURY, Md.Aug. 24, 2017 /PRNewswire/ — POA, a large regional orthopaedic specialty group, announced their first successful implant of MACI® (autologous cultured chondrocytes on a porcine collagen membrane) in the region. MACI is an FDA-approved product, in which a patient’s own cartilage cells from the knee are regrown in a laboratory and implanted back into the patient’s knee to repair the defect.

With the introduction of MACI, surgeons now have an FDA approved product in which the patient’s own cells can be reproduced in a controlled lab environment, embedded on a special collagen membrane, and then implanted in the knee using a minimally invasive technique. “Joint preservation surgery has undergone its next evolution.  With this new technology, we can use a patient’s own cells to grow new cartilage to preserve their joint.  The scaffold which delivers their cells allow for minimally invasive surgery and smaller incisions.  We are working on an all-arthroscopic technique, as well.  While this operation will not work for an arthritic knee, it has the promise of preserving a knee and potentially preventing future arthritis,” says Orthopaedic Surgeon Dr. Jason Scopp.

About MACI

MACI® (autologous cultured chondrocytes on a porcine collagen membrane) is an autologous cellular scaffold product that is used in the repair of symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement in adults. The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from a patient’s own cartilage for the manufacturing of MACI. The FDA approval of MACI was supported by the results of SUMMIT trial, a Phase 3 two-year trial.

About POA

Peninsula Orthopaedic Associates is a multi-specialty orthopaedic practice with offices in Berlin and Salisbury, Marylandand Millsboro and Seaford, Delaware. With over 50 years of providing comprehensive orthopaedic care, we provide expertise in foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine, joint replacement, joint preservation, orthopaedic trauma care, performance enhancement and rehabilitation, and biologic solutions, in order to offer an expansive continuum of care for our region.

For more information, please visit the MACI website at, or contact Jessica Ennis at
410-860-4506 or

SOURCE Peninsula Orthopaedic Associates


August 24, 2017 OrthoSpineNews

August 23, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, today has announced that it has expanded its Field of Use definition of the license agreement with the UCLA Technology Development Group on behalf of UC Regents for NELL-1. Additionally, Bone Biologics has entered into an exclusive license agreement with the UCLA Technology Development Group on behalf of UC Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer.

“Following the completion of several key milestones, Bone Biologics is pleased to include two additional indications to its portfolio,” said Stephen LaNeve, CEO and President of Bone Biologics. “In addition to the company’s work in spine fusion, this exclusive license agreement for trauma and osteoporosis, further supports the possibility of NELL-1 becoming a proprietary platform technology.”

Most current osteoporosis therapies are designed to slow bone loss and prevent it from worsening but research involving NELL-1 is being examined to systemically restore bone and prevent further loss.

About Bone Biologics

Bone Biologics (OTC: BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work and building on unprecedented research on the NELL-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. NELL-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTC; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.


This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.


Bone Biologics
Jeff Frelick, Chief Operating Officer
Compass Investor Relations
Mark Collinson, 714-222-5161
Media Inquiries:
Tracy Williams, 310-824-9000