KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of the Investigational Device Exemption (IDE) application submitted by CartiHeal for their Agili-C™ implant, towards a PMA application.

The 2 year-long pivotal study will involve a minimum of 250 patients in US and OUS centers. The study is aimed to show superiority of the Agili-C™ implant over surgical standard of care, i.e. microfracture and debridement, in the treatment of cartilage/osteochondral defects in both osteoarthritic knees and in knees without degenerative changes, making it the first approved study of such broad indications using a single implant.

The study is designed as a prospective, multicenter, open-label, randomized and controlled trial, involving up to 3 lesions in the same joint and with a total treatable area of 1-7cm².

Agili-C™ was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 220 patients with cartilage lesions in the knee, ankle and great toe. In these trials the implant was used for the treatment of a wide spectrum of cartilage lesions, according to its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Results of these prior investigations demonstrated the potential for cartilage regeneration and remodeling of the underlying subchondral bone, along with pain and symptom relief.

“Pivotal studies performed to date were always focused on small, focal and isolated cartilage lesions in a narrowly defined patient group, which does not represent most of the ‘real-life’ cases,” explains Dr. Ken Zaslav, President of the International Cartilage Repair Society (ICRS) and a member of CartiHeal’s Clinical Advisory Board. “Based on the robust clinical data of the Agili-C™ implant, FDA has allowed  for the first time, treatment indications ranging from single focal defects to multiple defects in osteoarthritis of the knee, which is what us surgeons see on a daily basis.  Moreover, this exciting study will compare two control modes in a single arm:  microfracture for the treatment of focal lesions and debridement for patients with osteoarthritis.”

“Over the last few years we’ve conducted a series of clinical studies in leading centers to learn which kind of patients can  benefit from the Agili-C™ implant,” says Nir Altschuler, CartiHeal’s founder and CEO.  “Together with our Clinical Advisory Board we designed a study that targets a large patient population who can potentially benefit from this implant. We are very pleased that FDA approved our study design, and believe that the Agili-C™ implant will prove to be an ideal treatment for a variety of cartilage lesions in patients who wish to return to a painless and active lifestyle, and currently don’t have good alternatives.”

About CartiHeal

CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

Backed by extensive pre-clinical and clinical data, its flagship product Agili-C™, an aragonite-based biodegradable scaffold, has been shown to promote restoration of hyaline cartilage and remodeling of its underlying subchondral bone through a natural process, without the use of cells or growth factors.

Clinical results in the knee, ankle and big toe demonstrated the potential of significant improvement in pain reduction, as well as reduction in related symptoms – through a simple, single-step implantation procedure.

In the United States, the Agili-C is an investigational device that is limited to use in the IDE study.  It is not available for sale.

Media Contact:
Caty Pearl
Caty@pearlcom.co.il
+972-548081020

SOURCE CartiHeal (2009) Ltd.

Jim Dickinson, Posted in Regulatory and Compliance by MDDI Staff on December 16, 2016

Emerging like the campaign that preceded it as the most unconventional in history, the incoming Trump Administration has many conservatives clambering aboard his train, expecting big changes—including relief for industries regulated by FDA.

For that to come about, much will depend on Trump’s choice for Secretary of HHS, six-term Atlanta-based congressman and orthopedic surgeon Tom Price, who has displayed little interest in the agency other than to unsuccessfully vote against it being given regulatory control over tobacco products.

His main focus is expected to be on repealing and replacing Obamacare, a mission more in keeping with his track record of concentrating on economic issues affecting his fellow physicians and the hospitals they operate in.

A secondary focus will be implementing the new 21st Century Cures Act, which does have a bit to say about FDA and especially about the agency’s treatment of medical devices. Price was among the lopsided 392-26 majority that voted for it in the House.

A strong supporter of “medical innovation,” as he put it then, Price in 2015 voted against the first version of this bill, complaining that it “sets an unacceptable precedent—particularly at a time when so much of our federal budget is already on auto-pilot, increasingly difficult to control and a significant risk to America’s fiscal well-being. I stand ready to work with my colleagues in advancing funding for health care research and to do so in a responsible manner.”

The Cures act will force some awareness of FDA on Price because of its provisions affecting reviews of new devices, drugs, and combination products.

READ THE REST HERE

Audrey Turley and Thor Rollins – Posted in Testing Services by MDDI Staff on December 20, 2016

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed “adulterated” products. Adulterated includes the addition of fillers of reduced “quality or strength;” coloring to conceal “damage or inferiority;” formulation with additives “injurious to health;” or the use of “filthy, decomposed, or putrid” substances in a product. It took until 1995 for FDA to release an official guidance specific to medical device regulation.

This document, known as the “blue book,” was the basis of biocompatibility regulation for decades. FDA published a draft guidance document on the “Use of International Standard ISO 10993-1 ‘Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process’” in April 2013, and this draft marked the first updated direction regarding biocompatibility from FDA. A final version was issued in June of this year, which was officially adopted as the replacement for the G95 Bluebook memorandum on September 14, 2016.

During the three years that the document circulated as a draft, it doubled in length providing great insight into FDA’s regulatory expectations and the agency’s interpretation of the ISO 10993-1 guidelines in general. FDA guidance document on the use of ISO 10993-1 outlines the testing approach necessary to bring a medical device to market. Medical device manufacturers need to consider FDA’s interpretation of the ISO 10993-1 standard.

This guidance document can be divided into three areas: current thinking, new trends, and justification information. Current thinking references statements or thought processes that are recent trends from FDA as seen in feedback from medical device submissions. New themes are areas of updated insight or clarification of approaches to be taken. Justification information provides alternatives to the standard in vitro/in vivo biocompatibility tests in addressing specific biological endpoints.

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PORTLAND, OREGON (PRWEB) DECEMBER 21, 2016

Acumed is pleased to announce that it has reached a resolution of a patent infringement dispute involving Acumed’s US Patent No. 6,030,162 and the Skeletal Dynamics REDUCT Headless Compression Screws (Acumed LLC v. Skeletal Dynamics LLC, Case No. 3:15-CV-01581, filed in US District Court for the District of Oregon). As part of the settlement, Skeletal Dynamics has agreed to license Acumed’s patent for the remainder of its term.

The patent pertains to the design of one of Acumed’s flagship products, the Acutrak® Headless Compression Screw. Introduced in 1994, Acutrak is the original fully threaded headless compression screw with continuously variable thread pitch.

The unique, continuously variable thread pitch ensures each screw rotation threads new bone along the Acutrak screw’s entire length. As each successive individual thread advances faster than the trailing thread counterpart, the conical shape becomes seated into bone. This radial expansion of the screw threads, combined with their axial advancement, creates the ability to reduce and compress bone fragments without a traditional screw head.

In this way, Acutrak technology overcame the limitations of conventional bone screws that could not pass threads across a fracture site to create compression. By allowing each thread along the entire length of the screw to aid in reduction and compression, compression can be maintained as the threads cross the fracture site.[1]

Traditional bone screws have a narrow window of compression. The Acutrak screw has a larger window of compression than traditional screws due to the additive property of each thread providing compression. Mechanical studies show that the Acutrak screw provides the greatest push-out force, highest amount of retained compression after cyclic loading, and highest resistance to torsional loading compared to AO and Herbert screws in cadaveric and synthetic bone material.[2]

Backed by 25 years of clinical data and referenced in more than 100 studies in peer-reviewed journals, the Acutrak family of screws has demonstrated efficacy in hand, wrist, foot, and ankle applications.

More than 1.5 million Acutrak® and Acutrak 2® screws have been implanted to date.[3]

For more information about the Acutrak product line, please visit the Acutrak product page on the Acumed website.

About Acumed
Acumed LLC is a global leader of innovative orthopaedic implant solutions. Founded in 1988, Acumed is headquartered in Hillsboro, Oregon, with offices and a distribution network around the world. Acumed is dedicated to developing products, service methods, and approaches that improve patient care. For more information, please visit http://www.acumed.net.

Availability
These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. Specific questions physicians may have about the availability and use of the products described on these materials should be directed to their particular local sales representative. Specific questions patients may have about the use of the products described in these materials or the appropriateness for their own conditions should be directed to their own physician.

References
1. Data on file at Acumed
2. Wheeler DL, McLoughlin SW. Biomechanical assessment of compression screws. Clin Orthop Relat Res.1998;350:237–245.
3. Acumed sales reports

December 15, 2016