FDA May Outlast Trump’s Change Agenda

Posted On December 21, 2016 By OrthoSpineNews In Regulatory /

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.

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How the New FDA Guidance on Biocompatibility Affects Medical Device Manufacturers

Posted On December 21, 2016 By OrthoSpineNews In Regulatory /

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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Should Medicare Allow Outpatient Knee Replacement? Doctors Are Deeply Split

Posted On December 21, 2016 By OrthoSpineNews In Financial /

By CHRISTINA JEWETT – DEC. 20, 2016

Five years ago, Dr. Ira Kirschenbaum, an orthopedic surgeon in the Bronx who replaces more than 200 knees each year, would have considered it crazy to send a patient home the same day as a knee replacement operation.

And yet there he was this year, as the patient, home after a few hours. A physician friend pierced his skin at 8 a.m. at a Seattle-area surgery center. By lunch, Dr. Kirschenbaum was resting at his friend’s home, with no pain and a new knee.

“I’m amazed at how well I’m doing,” Dr. Kirschenbaum, 59, said recently in a phone interview, nine weeks after the operation.

What felt to Dr. Kirschenbaum like a bold experiment may soon become far more standard. Medicare, which spends several billions of dollars a year on knee replacements for its beneficiaries — generally Americans 65 and older — is contemplating whether it will help pay for knee replacement surgery outside the hospital, in either free-standing surgery centers or outpatient facilities.

The issue is sowing deep discord in the medical world, and the debate is as much about money as medicine. Some physicians are concerned that moving the surgery out of hospitals will land vulnerable patients in the emergency room with uncontrolled pain, blood clots or other complications.

But proponents of the change say it can give patients more choice and potentially better care, as well as save Medicare hundreds of millions of dollars. Already, an “overwhelming majority” of commenters said they want to allow the operations out of hospitals, according to recent rule-making documents.

The final decision, which could come within a year, would also act as a test of sorts for Donald J. Trump and his new administration. They will weigh whether to limit government controls, as Mr. Trump has often suggested, or to bend to pressure from hospitals and doctors, many of whom oppose the change.

“I think the question will come down to two things,” said David Muhlestein, senior director for research at Leavitt Partners, a leading health consulting firm. “It’s the balance of trying to reduce regulations and let the market function — and the competing interest of vested parties.”

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Stryker to build $130-million corporate campus in Portage, add 105 jobs

Posted On December 21, 2016 By OrthoSpineNews In Financial /

By Tom Haroldson | Special to MLive

PORTAGE, MI – Stryker Corp. plans to build a $130-million corporate campus on nearly 300 acres in Portage, creating an estimated 105 new jobs over three years.

The proposal for Stryker’s medical instruments division involves 485,000 square feet of facilities that will include a customer experience center, functioning showroom, state-of-the-art research and development lab and a bio-skills lab for research and new product development. It will also include ffice space for sales, marketing and support functions.

The new campus will be built on 288 acres of land zoned industrial and bordered by Portage Road, East Milham Avenue and Ramona Avenue that Stryker purchased in October from Pfizer Inc. for $8.5 million, according to city documents.

The land is undeveloped and is near other Stryker facilities on Portage, Sprinkle and Romence roads. The company’s world headquarters is on Airview Road, just up Portage Road from the project property.

The Michigan Economic Development Corp. announced the project Tuesday, Dec. 20 in a press release. The agency’s Michigan Strategic Fund Board approved a $1 million grant for the project. The money will be primarily used to offset recruiting and training costs.

Stryker is expected to ask the city of Portage for a tax break in February and Kalamazoo County for brownfield redevelopment assistance.

City officials, who have known of the project for weeks, are elated.

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Acumed Reaches Agreement Regarding Patent Infringement of Acutrak® Screw

Posted On December 21, 2016 By OrthoSpineNews In Regulatory /

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

Whistleblowers Claim MiMedx Group, Inc. Defrauded Investors in Lawsuit Filed by Halunen Law

Posted On December 20, 2016 By OrthoSpineNews In Regulatory /

December 15, 2016

MINNEAPOLIS–(BUSINESS WIRE)–The MiMedx Group (NASDAQ: MDXG) persistently inflated its quarterly revenue figures over several years, using a fraudulent practice known as “channel stuffing” to book sales of products that customers never ordered, according to a whistleblower lawsuit filed by Halunen Law against the company and its CEO today in federal district court in Minneapolis.

When two top company sales people objected to being part of what they perceived to be a scheme to defraud shareholders and the investing public, senior-level executives retaliated with threats, intimidation, and ultimately, termination, according to the lawsuit.

Filing the lawsuit on behalf of the plaintiffs, Jess Kruchoski and Luke Tornquist, is the Halunen Law firm of Minneapolis.

“The lawsuit alleges that MiMedx retaliated in a punitive and illegal manner against our clients, after they objected to the company’s alleged illegal practice of booking phantom sales of one of its most lucrative product lines, EpiFix, in an effort to shore up its legally-required quarterly financial reports to shareholders,” says Clayton Halunen, managing partner of the firm and lead attorney for the plaintiffs.

According to the lawsuit, the scheme implicates AvKARE, Inc., a Tennessee company that entered into a distribution agreement with MiMedx, and the Department of Veterans Affairs, an end customer of MiMedx products. Kruchoski and Tornquist allege that MiMedx directed sales managers and representatives to book large orders for products never requested by their customers, VA hospitals in the Upper Midwest. Typically, the “requests” to write these orders were issued in the waning days of a quarterly reporting period, with the goal of inflating the company’s quarterly revenue reports to shareholders, the lawsuit claims. The complaint further alleges that this scheme did not comply with generally accepted accounting principles for revenue recognition.

According to the complaint, when a company directive ordering sales personnel to “stuff the shelves” of VA hospitals with EpiFix packages came down in late December 2015, Kruchoski expressed his opinion about the illegality of such action. However, as alleged in the Complaint, on December 30, MiMedx CEO Parker Petit ordered the sales force to add inventory to government shelves.

According to the complaint, the company unveiled a new tactic to use in supplying VA hospitals with an abundance of EpiFix products in March 2016. The idea allegedly called for using FedEx to ship shoebox-sized packages filled with 15 of the most expensive EpiFix grafts to VA hospital shipping departments. The Complaint alleges that in late March, MiMedx shipped what was estimated to be about $2.4 million worth of product to VA hospitals nationwide. As of November 2016, much of this product was returned or remained on the VA shelves, unpurchased. The complaint describes at least one instance of the EpiFix grafts being stored at a sales representative’s home.

In early November, Kruchoski and Tornquist jointly submitted a report to corporate officials identifying MiMedx’s improper revenue recognition scheme as a violation of the federal Sarbanes-Oxley Act of 2002 (SOX), says the complaint. Over the next weeks, according to the complaint, Kruchoski and Tornquist were threatened, and ultimately terminated.

Both Kruchoski and Tornquist, allege in their complaint that the company retaliated against them because they formally declared their concerns over the channel-stuffing practice. They further claim this retaliation violates the whistleblower protection embedded in SOX, the Dodd Frank Wall Street Reform and Consumer Protection Act, and the Minnesota Whistleblower Act.

About Halunen Law

Halunen Law is a national whistleblower law firm with offices in Minneapolis and Chicago, offering experienced legal representation to protect whistleblowers who have experienced retaliation or are planning to blow the whistle. They also offer experienced legal representation to individuals who are blowing the whistle on government fraud under the False Claims Act and other statutes. For more information on Halunen Law, visit the firm’s website at http://whistleblower.halunenlaw.com/.

Case 0:16-cv-04171 Download the complaint at: https://1drv.ms/f/s!Apr_gPRDSPDNgfww6C1lM2CNA3PfKg

Contacts

Halunen Law
Mack Reed, 612-605-4098
reed@halunenlaw.com

TransEnterix Announces Common Stock Purchase Agreement by Institutional Investor, Lincoln Park Capital Fund, LLC

Posted On December 20, 2016 By OrthoSpineNews In Financial /

December 20, 2016

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced today that it has entered into a common stock purchase agreement (“Commitment”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), a Chicago-based institutional investor.

According to the terms and conditions of the Commitment, TransEnterix will have the right, in its sole discretion, to sell to Lincoln Park up to $25.0 million in shares of the Company’s common stock over a 36-month period. Any common stock sold to Lincoln Park will occur at a purchase price based on the Company’s prevailing market prices at the time of each sale to Lincoln Park. TransEnterix will control the timing and amount of any sales to Lincoln Park, and Lincoln Park will be obligated to make purchases in accordance with the stock purchase agreement. Proceeds will be used for general corporate purposes.

“The Company expects this Commitment to provide us with additional balance sheet strength and to help continue funding our Senhance regulatory and commercial efforts,” said Todd M. Pope, President and CEO at TransEnterix.

There are no upper limits on the price Lincoln Park may pay to purchase common stock from TransEnterix. No warrants, derivatives, financial or business covenants, or rights on future financings are associated with the Commitment, and Lincoln Park has agreed not to cause or engage in any direct or indirect short selling or hedging of the Company’s common stock. In consideration for entering into the Commitment, TransEnterix issued shares of common stock to Lincoln Park as a commitment fee and additional shares of common stock will be issued to Lincoln Park pro rata as shares of common stock are sold to Lincoln Park pursuant to the Commitment. The stock purchase agreement may be terminated by TransEnterix at any time, at its sole discretion, without any additional cost or penalty.

A more detailed description of the stock purchase agreement and the Commitment is set forth in the TransEnterix’s Current Report on Form 8-K as filed with the SEC on December 19, 2016, which the company encourages you to read.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the described offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

About TransEnterix, Inc.

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

About Lincoln Park Capital Fund, LLC.

Lincoln Park is an institutional investor headquartered in Chicago, Illinois. Lincoln Park’s experienced professionals manage a portfolio of investments in public and private entities. These investments are in a wide range of companies and industries emphasizing life sciences, specialty financing, energy and technology. Lincoln Park’s investments range from multiyear financial commitments to fund growth to special situation financings to long-term strategic capital offering companies certainty, flexibility and consistency. For more information, visit www.lpcfunds.com.

Forward Looking Statements

This press release contains “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Commitment will provide the company with additional balance sheet strength as anticipated. For a discussion of the risks and uncertainties associated with TransEnterix’s business, including those related to the regulatory approval for and commercialization of our products, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 3, 2016, our most recent periodic report on Form 10-Q, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1 415-618-8750
TransEnterix-SVC@sardverb.com

InVivo Therapeutics Announces New Patient Enrollment into the INSPIRE Study

Posted On December 20, 2016 By OrthoSpineNews In Biologics, Neuro /

December 20, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that a new patient with a T8-9 fracture dislocation injury has been enrolled into The INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at the Carolinas Medical Center in Charlotte, NC. Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee, performed the implantation with his partner, Samuel Chewning, M.D. Surgery was performed approximately 19 hours after the injury occurred. Dr. Coric and Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-principal Investigators at this site.

“Implantation of the Neuro-Spinal Scaffold went smoothly and the patient is doing well,” Dr. Coric said. “I have now implanted five patients with different injury types and locations, and the implantation procedure has been consistently uncomplicated. I look forward to following this most recent patient’s progress.”

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We now have ten INSPIRE patients enrolled and in follow up, which is an important milestone in this study designed to enroll 20 evaluable patients. We thank Dr. Coric and his team for having enrolled five patients at their site, and look forward to continuing to make progress toward full enrollment.”

For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the expected timing of additional enrollment. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com

OrthoSpace Announces Publication of Positive Results for the InSpace™ System in the Treatment of Massive Rotator Cuff Tears

Posted On December 20, 2016 By OrthoSpineNews In Sports Medicine /

CAESAREA, ISRAEL (PRWEB) DECEMBER 16, 2016

OrthoSpace Ltd. (“OrthoSpace” or “Company”) today announced a publication in the December issue of Musculoskeletal Surgery citing positive results for their InSpace System in the surgical treatment of massive rotator cuff tears (MRCTs). Patients undergoing the InSpace procedure experienced durable improvements in shoulder function and reductions in shoulder pain at 12 months of follow-up, demonstrating the benefits of InSpace as an effective alternative to existing surgical treatments.

The InSpace System consists of a biodegradable balloon spacer that is implanted in the subacromial space of the shoulder. InSpace is designed to address the challenges of MRCTs where surgery often fails and for which there is not current consensus or definitive guidelines for optimal surgical treatment. The procedure may be performed arthroscopically, or under fluoroscopy guidance, as presented in the study.

Patients with advanced age, diminished health status and comorbidities such as cardiovascular disease may be at a higher risk for complications when subjected to general anesthesia. The option to receive InSpace under fluoroscopy guidance addresses the unmet needs associated with this patient population, as the procedure is performed under local anesthesia.

“InSpace has been demonstrated to improve patient shoulder function and reduce pain in a difficult-to-treat population where conservative options have been exhausted and surgery under anesthesia would pose high risks to the patient,” said Enrico Gervasi, M.D., the study’s principal investigator and the Director of Orthopedic and Trauma Surgery at Latisana Civil Hospital at Udine, Italy. “Further, the procedure is technically easy to perform, taking only ten minutes to deploy the spacer, and can be performed under local anesthesia in the outpatient setting.”

This ongoing clinical study of the InSpace System will ultimately enroll up to 45 patients, all of whom will be followed for up to 24 months. The study population consists of elderly patients who are not candidates for surgery under general anesthesia and who did not respond to conservative treatment, including steroid injections and physical therapy. This publication represents a planned interim analysis of the first 15 patients enrolled, who were considered evaluable upon reaching 12 months of follow-up. All 15 patients in this cohort experienced overall improvements in shoulder function, as measured by the Constant Score and the American Shoulder and Elbow Surgeons Evaluation Form (ASES). Of these patients, 85% showed a clinically significant improvement in their Constant Score. Improvements were observed beginning at 6 weeks post treatment and sustained for at least 12 months post-treatment. Additionally, patients reported significant improvements in pain scores.

“We are pleased with these results from Dr. Gervasi and colleagues. These data reinforce and continue to build on the existing data supporting the use of InSpace for patients with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “The cases represent an unmet clinical need, and we are proud to offer additional surgical options for patients who are suffering from pain and immobility associated with this difficult indication.”

About OrthoSpace Ltd.

OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company’s product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.

Skin cells ‘crawl’ together to heal wounds treated with unique hydrogel layer

Posted On December 20, 2016 By OrthoSpineNews In Biologics /

December 14, 2016 – Credit: Marit Mitchell / U of T Engineering

Time may not heal all wounds, but a proprietary mix of peptides and gel developed by U of T Engineering researchers heals most.

A team led by Professor Milica Radisic has demonstrated for the first time that their peptide-hydrogel biomaterial prompts skin cells to “crawl” toward one another, closing chronic, non-healing wounds often associated with diabetes, such as bed sores and foot ulcers.

The team tested their biomaterial on healthy cells from the surface of human skin, called keratinocytes, as well as on keratinocytes derived from elderly diabetic patients. They saw non-healing wounds close 200 per cent faster than with no treatment, and 60 per cent faster than treatment with a leading commercially used collagen-based product.

“We were happy when we saw the cells crawl together much faster with our biomatieral, but if it didn’t work with diabetic cells, that would have been the end of the story,” says Radisic. “But even the diabetic cells travelled much faster — that’s huge.”

Until now, most treatments for chronic wounds involved applying topical ointments that promote the growth of blood vessels to the area. But in diabetic patients, blood vessel growth is inhibited, making those treatments ineffective. Radisic and her team have been working with their special peptide — called QHREDGS, or Q-peptide for short — for almost 10 years. They knew it promoted survival of many different cell types, including stem cells, heart cells and fibroblasts (the cells that make connective tissues), but had never applied it to wound healing.

“We thought that if we were able to use our peptide to both promote survival and give these skin cells a substrate so they could crawl together, they would be able to close the wound more quickly,” says Radisic. “That was the underlying hypothesis.”

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