FDA Commissioner Scott Gottlieb, M.D. on FDA’s new policy steps and enforcement efforts of stem cell therapies and regenerative medicine

Posted On August 28, 2017 By OrthoSpineNews In Biologics, Regulatory /

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

RMAT

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, lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Regentis Biomaterials Receives European CE Mark Approval for GelrinC

Posted On August 28, 2017 By OrthoSpineNews In Biologics, Regulatory, Top Stories /

OR AKIVA, Israel and PRINCETON, New Jersey, August 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 http://www.regentis.co.il.

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

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

Kuros receives clearance for MagnetOs Putty for commercialization in the United States and files the product for CE marking in Europe

Posted On August 28, 2017 By OrthoSpineNews In Biologics, Regulatory /

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

harry.welten@kurosbio.com

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 www.kurosbio.com 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.

Peninsula Orthopaedic Associates Announces First MACI Implant in the Region for the Treatment of Cartilage Defects of the Knee

Posted On August 24, 2017 By OrthoSpineNews In Biologics, Extremities, Top Stories /

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 maci.com, or contact Jessica Ennis at
410-860-4506 or jennis@peninsulaortho.com.

SOURCE Peninsula Orthopaedic Associates

MiMedx Signs Definitive Agreement to Divest Stability Biologics Subsidiary as Company’s Strategic Focus on Biopharma

Posted On August 21, 2017 By OrthoSpineNews In Biologics /

MARIETTA, Ga., Aug. 18, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that it has signed a definitive agreement with the former stockholders of Stability Inc. to divest the Company’s subsidiary, Stability Biologics LLC (f/k/a Stability Inc.) back to those stockholders.

The recent announcement by the Company to transition into a biopharmaceutical company was an impetus for this divestiture initiative. Acquired by MiMedx in January 2016, Stability Biologics developed and processed bioactive bone graft products and tissue allografts including structural/particulate bone, structural allografts, demineralized bone matrix (DBM), skin products for burns and traumatic wound care, and Physio®, a bone grafting material. MiMedx acquired Stability Biologics with a combination of cash and stock paid at closing, with future contingent consideration to be paid through a two-year earn-out arrangement.

Parker H. “Pete” Petit, MiMedx CEO, said, “We remain very confident in our growth trajectory continuing and in our ability to meet or exceed the revenue projections we have previously set for 2017. In our press release of July 26, 2017, we raised our annual revenue guidance to the range of $309 million to $311 million. Assuming this transaction closes in the third quarter, we will maintain our full year revenue guidance. Even without the Stability Biologics revenue contribution in the fourth quarter, we are confident in our ability to meet our increased revenue guidance for the year. As such, we are also reaffirming all other guidance ranges for the third quarter and full year 2017 as communicated in our July 26 press release.”

Petit added, “We have determined that the Stability Biologics business is not a strategic fit with our new focus on becoming predominantly a biopharmaceutical company. While we believe the potential of Stability Biologics products continues to be significant, we expect to have better return on investment (ROI) opportunities in biopharma compared to those in the cadaver tissue category. A major incentive for the MiMedx acquisition of Stability Biologics was its independent sales representative organization. As part of the transaction, MiMedx will retain access to this sales rep organization via a distributor agreement with Stability. This group of sales reps will continue to focus on certain areas of our surgical business.”

Petit continued, “Our human placental tissue allografts are the source material for our primary asset base, which is a key technology differentiator in regenerative biologics. We are focusing our efforts on continuing down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our placental-based technology. MiMedx will continue to demonstrate, through scientific and clinical studies and trials, the clinical and economic effectiveness of our regenerative biologics and therapies. After this divesture, MiMedx’s gross profit and operating profit margins are expected to improve.”

Mike Senken, MiMedx CFO, commented, “The transaction is expected to be completed in the third quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. of all claims and rights to the Earn-Out consideration. The Company expects to book a one-time gain on this transaction of approximately $8 million to $10 million.”

Bill Taylor, MiMedx President and COO, commented, “Our infrastructure has been carefully adjusted and assembled to pursue our biopharma strategy. With this new strategic focus, the long-term strategy of Stability Biologics is no longer a strategic fit for MiMedx. That said, through a new “private label” distribution agreement with Stability Biologics, we have retained their key sales relationships for the spine and orthopedics areas of our surgical business.”

Brian Martin, CEO of Stability Biologics LLC, added, “We have enjoyed our association with MiMedx and believe we have benefited a great deal during our time as part of the MiMedx organization. We believe this transaction is a very positive event for both companies.”

About MiMedx

MiMedx® is a biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement

This press release includes forward-looking statements, including statements regarding the Company’s confidence in its overall growth trajectory in 2017 and ability to meet revenue projections for the year even without revenue from Stability Biologics, the Company’s expectations regarding the gain on the transaction, the Company’s belief that the potential for Stability Biologics continues to be significant, the Company’s belief that it will have better return on investment in the biopharma category compared to cadaver tissue, that the Company’s placental tissue allografts are its technology differentiator, that the Company will continue to be able to demonstrate the clinical and economic effectiveness of its regenerative biologics and therapies, the Company’s belief that its gross profit and operating margins will improve post-divestiture, and the Company’s belief that the distributor agreement with Stability Biologics retains key sales relationships for the Company. Forward-looking statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations.

Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that any of the Company’s growth, revenue, and gross profit and operating margins may not continue as expected or may decline, Stability Biologics may not continue to have great potential post-divestiture, that the financial impact of the transaction may not occur as predicted, that the Company may not experience better return on investment in biopharma over cadaver tissue or may not be able to adequately transition into the biopharma space to realize its perceived advantages, that the Company’s placental tissue allografts do not continue to be a technology differentiator as competition increases and/or new and different technologies are developed, and that the distributor agreement may fail to retain key sales relationships for the Company. For additional risks that might affect the Company, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

MiMedx Hits Milestone of One Million Allografts Distributed

Posted On August 9, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Aug. 9, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has now distributed over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are very pleased about hitting this impressive milestone of supplying our one millionth allograft. We are especially proud of the hundreds of thousands of patients that our allografts have aided in the healing of their respective conditions. The remarkable outcomes produced by the application of our allografts have assisted physicians and their patients in countless areas of care. These include recovery from acute and traumatic wounds that are debilitating and complex; avoidance of limb amputations; supporting various surgical applications to provide a barrier to reduce the amount of scar tissue formation, modulate inflammation and help with the soft tissue healing of the area; and repair and reconstruction of various soft-tissue injuries in or around joints caused by traumas or chronic conditions. The soft tissue injuries treated with our allografts affect various anatomical locations, mainly knee, shoulder, elbow, foot and ankle and hand and wrist injuries, as well as tendinopathies, tendinitis, tendinosis, tendon and ligament sprains, and ruptures.”

Bill Taylor, President and COO, added, “We are also extremely proud of our outstanding safety record. We have extremely stringent screening and quality standards in our recovery of donated placentas, and our patented processing methodology includes both aseptic processing as well as terminal sterilization, which enhances the safety and prevention of infectious disease transmission of our allografts. Moreover, our strict sterilization processes and proprietary processing methodology does not affect the cytokines, growth factors, regulatory proteins, chemokines and other critical factors that optimize the performance of the MiMedx allografts and enable our allografts to deliver the clinical results that Pete just referenced.”

“Our dehydrated human amnion chorion membrane (dHACM) allografts are described in an official United States Pharmacopeia and The National Formulary (USP-NF) Monograph, which sets the standards for drug substances, dosage forms, excipients, compounded preparations, dietary supplements, and medical devices. A USP-NF Monograph on a human tissue product is a very rare occurrence and a recognition that allografts claiming to be dHACM allografts are only those produced in conformance with these exceptionally high standards to avoid any potential for adulteration or misbranding. We are very proud to have that distinction,” added Petit.

“The areas of care that our allografts serve are a major burden on the American health care system in both the negative impact they have on the patient’s quality of life and functionality as well as the escalating costs of care. We are pleased that we have and will continue to play an expanding role in helping the healthcare community resolve these burdens by improving outcomes and reducing costs,” noted Chris Cashman, EVP and Chief Commercialization Officer.

In recognition of this achievement, we will be make a donation to a charity recommended by the physician that utilized our one millionth allograft,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Tissue Regenix Completes Acquisition of CellRight Technologies

Posted On August 9, 2017 By OrthoSpineNews In Biologics /

August 09, 2017

LEEDS, United Kingdom–(BUSINESS WIRE)–Tissue Regenix Group plc, a UK- based regenerative medical company (AIM:TRX) announces completion of the acquisition of CellRight Technologies LLC, a US based specialist in regenerative osteoinductive bone scaffolds.

The acquisition, expands the Group’s presence within the US healthcare market and increases US sales by more than double, bringing together two highly complementary technology and product platforms focused on soft-tissue regeneration and regenerative bone matrices, respectively.

TRX has built a portfolio of soft tissue products for use in wound care, orthopaedics and cardiac applications, based on its patented dCELL® Technology with DermaPure, a decellularized dermal allograft for chronic and acute wound care, currently commercialized. CellRight, brings a complementary regenerative technology which is used to turn allograft bone into various malleable applications including, DBM Putty, strips, blocks and fibres, primarily for use in spine, orthopaedics and dental surgeries.

Leveraging the capabilities of CellRight Technologies’ existing tissue bank in San Antonio, TX, Tissue Regenix is set to launch its OrthoPure™ HT, decellularized human tendon, into the U.S. orthopedics market in early 2018, which will initially address anterior cruciate ligament repair. This facility also provides the Group with a purpose built U.S. base to self-manufacture products utilizing its patented dCELL® process.

“The combination of TRX and CellRight Technologies is a crucial step in advancing our regenerative medicine capabilities for patients worldwide,” said Antony Odell, CEO, Tissue Regenix Group. “CellRight’s team have exceptional talent and experience, and their regenerative technology is highly complementary to our own dCELL® soft tissue platform. The benefits of the combined, broad portfolio of innovative soft tissue and bone products is clinically recognised. CellRight and TRX share a common goal and vision. Together, we can expedite and expand our research and development pipelines, increase our market presence both in the US and internationally and create more value for our stakeholders, both clinical and financial. I am pleased to welcome Jesus Hernandez and his team to the Tissue Regenix Group.”

Jesus Hernandez, Founder and CEO, CellRight Technologies: “I am excited to join the TRX team and continue the evolution of the CellRight Technologies products and brand. In TRX we have found a partner that shares our values and commitment to innovation and clinical outcomes. Our combination will allow us to bring our innovative products to a wider patient population and together, commercialise a pipeline of differentiated regenerative treatments.”

Important notice

The information contained herein is not for release, directly or indirectly, in or into Australia, Canada, Japan or the Republic of South Africa. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada, Japan or the Republic of South Africa or any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. No public offering of the securities will be made in the United States.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company’s patented decellularisation (‘dCELL®’) technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States – ‘Tissue Regenix Wound Care Inc.’, January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight’s human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.

Contacts

Tissue Regenix Group plc
Caitlin Pearson, 07920 272 441
Corporate Communications Director
or
Racepoint Global
Jeff Stoecker, +1-617-624-3424

Former Quadriplegic Enrolled in Asterias’ SCiStar Study to Throw Ceremonial First Pitch at Major League Baseball Game

Posted On August 8, 2017 By OrthoSpineNews In Biologics, Neuro /

FREMONT, Calif., Aug. 08, 2017 (GLOBE NEWSWIRE) — Asterias Biotherapeutics, Inc. (NYSE MKT:AST) today announced that Lucas Lindner of Eden, Wisconsin, a quadriplegic patient who has regained functional use of his fingers, hands and lower arms after receiving the company’s investigational stem cell therapy for complete cervical spinal cord injury, AST-OPC1, will throw out the ceremonial first pitch of a Major League Baseball game in Milwaukee on Sunday, August 13th.

“Lucas has been an inspiration to our employees at Asterias who have worked so hard to bring AST-OPC1 to where it is now being administered to patients in a clinical trial, as well as to thousands of others who have seen his story on the internet or on television,” said Mike Mulroy, President and CEO of Asterias. “We are excited about the progress he has made since receiving 10 million cells of AST-OPC1 and look forward to cheering him on as he takes the field before the game.”

Lucas suffered a severe spinal cord injury when his car swerved off the road into a tree to avoid hitting a deer in May 2016. He was flown to the hospital and received immediate surgery to stabilize his spine. He was left without the ability to move his limbs below the neck and upper arms.

In June 2016, Lucas received 10 million cells of AST-OPC1 in Asterias’ ongoing SCiStar Phase 1/2a clinical study by Shekar N. Kurpad, MD, PhD, Sanford J. Larson Professor and Chairman, Department of Neurosurgery at the Medical College of Wisconsin and Director of the Froedtert & Medical College of Wisconsin Spinal Cord Injury Program. Lucas has since regained the ability to move triceps, hands and fingers.

As of his latest follow-up visit (12 months following administration of AST-OPC1), Lucas has achieved two motor levels of improvement on one side of his body. As suggested by existing research, patients with severe spinal cord injuries that show two motor levels of improvement on at least one side may regain the ability to perform daily activities such as feeding, dressing and bathing, which significantly reduces the overall level of daily assistance needed for the patient and associated healthcare costs.

“Throwing out the first pitch at a Major League game is not something I could have imagined a year ago,” said Lucas. “I want to show everyone that there is hope that spinal cord injury patients can regain function. I am looking forward to going back to school, pursuing my dream of working in the IT field and living independently someday.”

“When I first met Lucas about a year ago, he had some use of his arms and little to no use of his hands or fingers,” said Dr. Kurpad. “The fact that he is throwing out the first pitch at a Major League Baseball game is amazing. It illustrates the strides medical science is starting to make in helping paralyzed patients regain useful function. I’m very encouraged by the early results we are seeing with AST-OPC1 and am grateful for the improvement Lucas has made.”

Asterias has now completed enrollment and dosing in four of the five planned SCiStar study cohorts and enrolled twenty-two patients in the SCiStar study. Twenty-seven patients have been administered AST-OPC1 after including patients from a previous Phase 1 safety trial and results-to-date continue to support the safety of AST-OPC1. In June 2017, Asterias reported 9 month data from the AIS-A 10 million cell cohort that showed improvements in arm, hand and finger function observed at 3-months and 6-months following administration of AST-OPC1 were confirmed and in some patients further increased at 9-months. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during the remainder of 2017 and 2018.

To view a video on Lucas’ story, click on the following link: https://youtu.be/1DerDpM_FO4.

Broadcast quality b-roll footage is available for news media use by request by contacting mark@reachthenextlevel.com.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at eight centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago, Santa Clara Valley Medical Center in San Jose jointly with Stanford University, Thomas Jefferson University Hospital, in partnership with Magee Rehabilitation Hospital, in Philadelphia, and UC San Diego Health in San Diego.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries in the current SCiStar study, which represents the first targeted population for registration trials. Asterias has completed enrollment in the first four cohorts of this study. Results to date have continued to support the safety of AST-OPC1. Additionally, Asterias has recently reported results suggesting reduced cavitation and improved motor function in patients administered AST-OPC1 in the SCiStar trial.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

Contacts:
Investor Relations
(510) 456-3892
or
EVC Group, Inc.
Michael Polyviou/Greg Gin
(646) 445-4800

Media
Thomas D. Gibson
GIBSON Communications, LLC
(201) 476-0322 – Main
(201) 264-3646 – Mobile

Bioventus Names Greg Anglum Senior V.P and CFO, Tony D’Adamio Senior V.P and General Counsel

Posted On August 8, 2017 By OrthoSpineNews In Biologics /

August 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus^®, a leader in orthobiologic solutions, today announced two changes to its executive leadership team. Greg Anglum has been promoted to Senior Vice President and Chief Financial Officer. Anglum, who joined Bioventus in 2016 as its Chief Accounting Officer, brings more than 20 years of experience driving financial and growth strategies for both private and public companies in various industries. He will also be responsible for the business intelligence and IT teams at Bioventus.

In addition, Bioventus is pleased to announce Anthony (Tony) D’Adamio has joined the company as its Senior Vice President and General Counsel. D’Adamio has nearly 30 years of senior legal executive experience with diagnostic, health care data and clinical service companies. He will be responsible for all general and corporate legal matters as well as the ethics and compliance functions at Bioventus. Both Anglum and D’Adamio will also join the company’s executive leadership team and report to its CEO, Tony Bihl.

“Greg has done an exceptional job serving as Interim CFO for the past three months, seamlessly integrating into our executive team in this important role. He has provided the financial reporting, guidance, analysis, and leadership that gives us great confidence in his ability to perform and grow moving forward,” said Bihl. “One of Tony’s strengths is his ability to provide exceptional legal advice while always seeking to achieve the best overall business solution. His global experience in complex regulated healthcare industries, along with his engaging and collaborative approach make him a great addition to our leadership team.”

Prior to joining Bioventus, Anglum held CFO positions at Overture, a Raleigh-based technology company and StrikeIron, a Software-as-a-Service (SaaS) company. He also spent several years in public accounting roles with Arthur Andersen and Grant Thornton. Anglum earned a Bachelor of Arts degree in economics from Vanderbilt University and an MBA from the Owen Graduate School of Management at Vanderbilt.

D’Adamio most recently served as General Counsel & Secretary of Siemens Medical Solutions and earlier was Deputy General Counsel & Secretary of Siemens Healthcare Diagnostics. He also spent five years as Senior Counsel within the Diagnostics Division of Bayer Healthcare, prior to the acquisition of this business by Siemens. D’Adamio began his legal career at the law firm of Bond, Schoeneck & King before taking corporate legal positions with companies including Group Health Incorporated, Quest Diagnostics and Covance. He received his Juris Doctor cum laude from Howard University School of Law and a Bachelor of Arts from the State University of New York at Binghamton.

About Bioventus

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

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

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

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

Anika Announces Publication of Data Demonstrating the Efficacy and Safety of HYALOFAST® in Combination with Stem Cells for the Treatment of Cartilage Lesions on the Knee

Posted On August 7, 2017 By OrthoSpineNews In Biologics, Top Stories /

August 07, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of data demonstrating that HYALOFAST^®, a biodegradable HA-based scaffold, used in combination with autologous adult mesenchymal stem cells (MSCs), regardless of a patients’ age, is a viable and effective option for the treatment of cartilage lesions of the knee joint. The data, published in the Knee Surgery Sports Traumatology Arthroscopy – Volume 25 – Number 8 edition of August 2017, demonstrated that treatment outcomes were equally effective among patients under the age of 45 as they were with patients over the age of 45, who are difficult to treat with traditional approaches such as microfracture.

“Cartilage lesions are reported in almost 2 out of 3 patients aged 40 to 50 years who are undergoing knee arthroscopy, and current interventions for cartilage repair have limited utility, in part due to the age-related decrease in regenerative potential of articular chondrocytes observed in vitro,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “This study shows that we may be able to fill a significant treatment gap in the management of cartilage defects among older patients, and offer a more convenient and cost-effective alternative or adjunct to traditional, invasive approaches such as microfracture with HYALOFAST.”

The study evaluated 40 patients with full thickness cartilage lesions of the knee joint, 20 of whom were over the age of 45 and the remaining, who were under the age of 45. All patients were implanted with HYALOFAST soaked in bone marrow aspirate concentrate (BMAC) containing MSCs, and were prospectively evaluated for 4 years. Functional outcomes were assessed using a variety of validated scales¹ preoperatively, at 2-years and at the final follow-up at 4 years. At final follow-up, all functional outcomes’ scores significantly improved (P < 0.001) in both groups of patients, and researchers concluded that the outcomes were not impacted by age or concomitant surgical procedures, but by the size and quantity of lesions.

“We’re encouraged by the results of this long-term study that shows the potential clinical utility of combining stem cells with the HYALOFAST biodegradable hyaluronic acid-based scaffold to treat cartilage defects in a simple one-step procedure,” said Alberto Gobbi, President of the OASI Bioresearch Foundation Gobbi NPO, visiting professor at the UC San Diego, the next President of the International Cartilage Repair Society (ICRS), and the study’s lead author. “One of the key learnings from our four-year follow-up was that cartilage lesion size and quantity might be a better indicator for surgery than advanced age, which we concluded did not impact outcomes associated with the use of stem cells and HYALOFAST.”

HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 11,000 patients to date. 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.

The full manuscript is available here: https://link.springer.com/article/10.1007/s00167-016-3984-6

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 www.anikatherapeutics.com.

¹ Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC), Knee Injury & Osteoarthritis Outcome Score (KOOS), and Tegner.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418, sonal@purecommunicationsinc.com

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