Month: November 2018

OrthoPediatrics Corp. Enhances Product Offering with Upgraded PediLoc® Femur Plate System

WARSAW, Ind., Nov. 27, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the U.S. launch of its new PediLoc® Femur Plate System. Building on the success of the existing PediLoc franchise, this upgraded offering boasts a lower profile screw to minimize soft tissue irritation, new locking drill guides, which simplify screw hole drilling and screw placement, and new 4.5mm straight locking compression plate options.

The breadth of this product offering allows surgeons to appropriately address multiple indications in patients with varying skeletal maturity levels by utilizing a plate that accurately fits the femur. Further, the enhanced system is configured for increased hospital and operating room synergy by utilizing OP’s existing core systems.

Joe Hauser, Vice President of Trauma & Deformity Correction, commented, “We are proud of our commitment to delivering innovative products to pediatric orthopedic surgeons. Our commitment to improve our legacy systems while also introducing new surgical systems demonstrates our dedication to providing superior surgical solutions for children. The PediLoc franchise is an important aspect of our business, and this enhanced system will provide our customers with new and improved implant options.”

About PediLoc Femur
The PediLoc Femur Locking Plate System is indicated for the treatment of pediatric femur fractures and osteotomies. The anatomic design of the stainless steel plates eliminates the need for intraoperative bending and contouring, while also providing superior fixation with either locking or non-locking screws.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024 /

Stryker announces pricing of €2.25 billion senior notes offering

Kalamazoo, Michigan, Nov. 27, 2018 (GLOBE NEWSWIRE) — Stryker (NYSE:SYK) announced today that it has priced the following notes: (i) €550 million aggregate principal amount of the Company’s 1.125% Notes due 2023 (the “2023 Notes”), (ii) €750 million aggregate principal amount of the Company’s 2.125% Notes due 2027 (the “2027 Notes”), (iii) €650 million aggregate principal amount of the Company’s 2.625% Notes due 2030 (the “2030 Notes”) and (iv) €300 million aggregate principal amount of the Company’s Floating Rate Notes due 2020 (the “Floating Rate Notes” and together with the 2023 Notes, 2027 Notes and 2030 Notes, the “Notes”).  Unless previously redeemed pursuant to their terms, if applicable, the 2023 Notes will mature on November 30, 2023, the 2027 Notes will mature on November 30, 2027, the 2030 Notes will mature on November 30, 2030 and the Floating Rate Notes will mature on November 30, 2020.  The Notes are expected to settle on November 30, 2018, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering for general corporate purposes, including the repayment of all of the $500 million principal amount of outstanding 1.800% Notes due January 15, 2019 at maturity and the repayment of all of the $750 million principal amount of outstanding 2.000% Notes due March 8, 2019 at maturity, as well as the repayment of any commercial paper then outstanding.

Barclays Bank PLC, BNP Paribas, Goldman Sachs & Co. LLC and J.P. Morgan Securities plc are acting as active joint book-running managers for the offering. This offering was made pursuant to a prospectus supplement, filed today, to the Company’s prospectus, dated February 12, 2016, filed as part of the Company’s effective shelf registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the notes may be obtained by contacting: (i) Barclays Bank PLC, 5 The North Colonnade, Canary Wharf, London E14 4BB, United Kingdom, or by calling 1-888-603-5847 or emailing, (ii) BNP Paribas, 10 Harewood Avenue, London NW1 6AA, United Kingdom, or by calling 1-800-854-5674, (iii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, or by calling (866) 471-2526, by faxing (212) 902-9316 or emailing or (iv) J.P. Morgan Securities plc, 25 Bank Street, Canary Wharf, London E14 5JP, United Kingdom, or by calling collect on +44-207-134-2468.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Forward-looking statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II recall matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The Company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.


For investor inquiries please contact:
Katherine A. Owen, Stryker, 269-385-2600 or

For media inquiries please contact:
Yin Becker, Stryker, 269-385-2600 or

UK firm sold spinal implants that disintegrated

26 Nov 2018 / 

A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed.

Documents seen by the Guardian show the plastic discs were approved for sale by the British Standards Institution (BSI) after tests on 30 people over six months.

A customised version was also implanted in nine baboons, according to a paper by members of the company’s own scientific advisory board.

The devices, made by the now-defunct Ranier Technology, which was based in Cambridge, are the focus of legal action brought by prosecutors in Germany against a doctor who implanted them, allegedly without first obtaining fully informed patient consent.

Many of the patients who received them are undergoing surgery to have them removed, with doctors finding some had completely disintegrated, according to an investigation coordinated by the International Consortium of Investigative Journalists, involving the Guardian and BBC’s Panorama.

Ranier Technology was granted CE (Conformité Européenne) safety marks for two implants, Cadisc-L and Cadisc-C. The devices were certified by the BSI in 2010 and 2011 respectively, and once approved were marketed to hospitals across Europe.

The firm gained millions of pounds in backing from investors impressed by its work in developing artificial spinal discs, which it said would bring relief and a normal quality of life to patients suffering degenerative disc disease.

Instead, about half of the patients given the Cadisc-L implants have had to undergo further surgery after the discs apparently disintegrated or moved in their backs, the Implant Files investigation has discovered.

The implants were seemingly beset by problems from the start, according to scientific analysis. The documents seen by the Guardian show that in trials on baboons using a custom-sized version of Cadisc-L the discs had all been put in the wrong place.

A 2009 review of some of the animals noted that “overall six months is a relatively short time to follow an implant up”, but even after that time there appeared “to be worrying changes between the implant and the bone in all but one subject”.

Details of the tests on humans have not been published, but it is known they only ran for six months before the CE mark application, even though the implants were aimed at young patients.

Medicrea Announces $30 Million Senior Secured Notes Issue and a Warrants Issue wholly subscribed by Perceptive Advisors

November 27, 2018

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572- ALMED ; OTCQX Best Market – MRNTY & MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, today announced the closing of a $30 million senior secured notes issue by Medicrea and wholly subscribed by Perceptive Advisors, a leading multi-strategy healthcare investment firm. In conjunction with the senior secured notes, Medicrea has issued to Perceptive Advisors warrants for the Company’s new ordinary shares.

Denys Sournac, Chairman of the Board of Directors and Chief Executive Officer, states “We are glad to execute this financing with Perceptive Advisors. The new secured notes will give us the necessary capital to continue to fuel our UNiD™ ASI growth strategy in the United States and will give us the required funds to continue the development of other proprietary products. We look forward to working with Perceptive, one of the leading healthcare focused investment firms in the world. We believe this refinancing is another validation of our proprietary, patient specific technology focused on restoring sagittal and coronal alignment.”

Sam Chawla, Portfolio Manager at Perceptive Advisors states, “We are excited about this investment in Medicrea. This refinancing retires most of the Company’s existing debt, and gives the company the financial flexibility to accelerate UNID™ ASI adoption. The company has a unique service and product offering in the Spine market and has delivered superior patient outcomes. With a clean capitalization, simplified balance sheet, and excess cash, Medicrea has a significant opportunity to grow over the coming years.”

Key Terms of the Notes

The refinancing facility will consist of $30 million senior secured and guaranteed notes, governed by New-York law with coupon based on the greater of Three-Month LIBOR or 2.5% plus a margin of 8.5%. The notes will be issued at par value on the 27th of November 2018, the expected date for the settlement and delivery, and will mature on the 27th of November 2022. The notes will be guaranteed by Medicrea USA Corp, a 100 % fully owned subsidiary of Medicrea and will be secured by pledges on certain assets and receivables of the Group.

This refinancing will help Medicrea fund its UNiD ASI growth strategy in the United States as well as continue to focus on new product development. Five years after its initial launch in September 2013, over 3,000 patients have benefited from UNiD™ ASI 100% proprietary pre-operative planning technologies and services associated with patient-specific spinal realignment rods. UNiD products have seen a strong acceleration in adoption rate in 2018 especially in the USA (+62% cases year-to-date 2018 and +90% in Q3 2018).

Medicrea has also retired all of its outstanding €15 million convertible debt with Athyrium Capital Management and will use the proceeds to pay down portions of other secured outstanding debt for a total amount of €1.55 million.

Medicrea believes this refinancing (excluding the exercise of the warrants) should support the development of the Company until it reaches operational profitability.

Key Terms of the Warrants

Perceptive Credit Holdings II,LP subscribed to 1,000,000 warrants. The settlement and delivery of the warrants should take place on the 27th of November, 2018. These warrants will not be subject to a request for admission to trading on the Euronext Growth market in Paris and will therefore not be listed.

One warrant entitles its holder to subscribe to one new Medicrea International ordinary share, at an exercise price of € 2.19, corresponding to the volume-weighted average of the share prices of the last 10 trading days prior to the fixing of the subscription price, decreased by a 10 % discount pursuant to the 14th resolution of the General Meeting of May 17, 2018. The warrants will be exercisable for a period of seven years after their issuance.

The new shares to be issued upon exercise of the warrants will carry current dividend rights and will be tradable on Euronext Growth and will be listed on the same line as the existing shares (ISIN : FR0004178572).

The shares that would be issued in the event of the exercise of all the warrants represent 4.93% of the Company’s share capital as of today (on a fully diluted basis).

For illustrative purposes, the interest of a shareholder holding 1% of the share capital of Medicrea would be brought to 0.94% if all the warrants were to be exercised.




Viseon, Inc. Announces First US Clinical Use of the Voyant System for Minimally Invasive Spine Surgery Access, Illumination and Visualization

November 27, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced the first U.S. clinical human use of the Voyant System for Minimally Invasive Spine Surgery access, illumination and visualization. The case was performed by Neurosurgeon John J. Knightly, MD of the Atlantic NeuroSurgical Specialists in Morristown, New Jersey. The Voyant System is composed of a sterile single-use, disposable retractor device with integrated state-of-the-art visualization technology. The system utilizes a reusable controller enabling digital intraoperative manipulation of the surgical site image, which is displayed on operating room HD flat-panel display monitors. The sterile device also allows the surgeon to adjust intraoperative depth of focus.

Dr. John J. Knightly, Vice Chair of Neurosciences and Medical Director of the NeuroSpine Program at Overlook Medical Center’s Atlantic Neuroscience Institute in Summit, NJ, stated, “The Viseon technology has the potential to significantly change how I perform minimally invasive spinal surgery procedures. The technology represents a compelling alternative for using a surgical microscope, with sufficient anatomical distinction and depth perception to safely perform these cases, in an easy to use, disposable system.”

Viseon President and CEO Jeffrey Valko stated, “We are grateful that Dr. Knightly has pioneered our first U.S. human case, demonstrating the procedural transition from surgical microscopes. Further, he confirmed the ergonomic and efficiency advantages of this innovative system.”

Viseon previously announced FDA 510k clearance of the Voyant System in October 2018 and is currently available in the U.S. on a limited basis.

About Viseon, Inc.

Viseon has developed a platform technology that has multiple opportunities for technological expansion, including wireless, neuro-monitoring and navigation, fluorescence, sensor integration and complementary robotic applications. The company has demonstrated clinical utility in posterior lumbar decompression and interbody fusion procedures and is expanding into lumbar lateral access and anterior cervical decompression fusion applications. The privately held medical device company is located in Irvine, California, founded in 2017, and recently completed an oversubscribed follow-on financing in October 2018.

For further information, please visit


Viseon, Inc.
Jeffrey J. Valko, (949) 662-3959

Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System.

The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customize to their preferred workflow through the utilization of either a traditional jamshidi/guide wire technique, awl-tap wireless technique, or single-step wireless technique for the placement of MIS pedicle screws. The system features an extensive offering of pedicle screw options, including iliac fixation, in either an extended tab (no assembly) or tower/screw (single step assembly) option. Designed to address even the most complex pathologies, Olympic MIS provides the versatility to accommodate multiple rod diameters in either titanium or cobalt chrome in pre-bent lordotic, straight, or pre-bent kyphotic options. The instrumentation further supports a streamlined and reproducible procedural sequence by providing up to 50mm of reduction, along with multiple options for compression or distraction, including the ability to span multiple levels simultaneously.

“With the increasing rates of MIS adoption and further complexity of pathologies being treated, it was paramount that we addressed the wide range of techniques that surgeons are currently utilizing,” said Joel Gambrell, President and CEO of Astura. “I’m proud of the system that our team of engineers and surgeon designers developed. Olympic MIS once again accomplishes our goal of continuing to bring technology to the market that further enhances the ability of our surgeon partners to provide the best in patient care.”

The full commercial release for Olympic MIS in December represents the fourth differentiated technology delivered to the market by the company in 2018.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical


Verrix Completes Initial Close on $8 Million Funding Round to Advance Sterility Assurance Technology for Hospitals

November 27, 2018

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Verrix, a medical device company developing solutions for rapid and accurate sterilization confirmation, has completed an initial close on a Series B funding round for $8 million, which will bring the company’s total funds raised to $17.5 million. The Series B funding will allow the company to finalize development, regulatory submission, and commercialization of its Verrix EVA™ Biological Indicator (BI) System.

“We are excited to see the rapid advancement of Verrix with strong support from our investors,” said Cameron Rouns, CEO of Verrix. “The company has achieved significant progress in the development of the Verrix EVA™ BI System and is well positioned to successfully transition to commercialization as it prepares to introduce new technology for the fight against hospital acquired infections.”

Biological indicator systems are used to verify the success of sterilization cycles and detect failures, as inadequately sterilized surgical instruments and implants are a major contributor to infection outbreaks in hospitals. Despite a strong focus on improvements in infection control practices and advancements in technology, 1.7 million hospital acquired infections (HAIs) occur every year in the U.S.,1 resulting in a $28-45 billion impact to the healthcare system.2 Recognizing that up to 70 percent of HAIs are preventable,2 Verrix technology is taking a new approach to sterilization monitoring to deliver BI results with unprecedented speed and accuracy.

Verrix was founded as a standalone company in 2013 to develop sterility assurance products and technologies based on planetary protection technology developed at NASA’s Jet Propulsion Laboratory for the Mars Rover program. In 2016, Verrix closed a Series A round of funding to develop the technology from patented concept to prototype. Verrix is now transitioning from research and development to commercialization of its unique method of spore detection. The first BI system developed based on Verrix’s technology advances is expected to be introduced in 2019.

To learn more about the history of Verrix, click here.

About Verrix

Verrix is a San Clemente, Calif.-based medical device company that is using the most advanced technologies to help protect patients from healthcare-associated infections. The foundational sterility assurance technology, originally discovered at NASA’s Jet Propulsion Laboratory, integrates cutting-edge optical physics, chemistry spectroscopy, and molecular biology. Based on scientific expertise and close partnerships with healthcare professionals, Verrix is developing market-changing solutions for sterility assurance, environmental monitoring, and infection control. Visit for more information.


  1. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160-166.
  2. Stone P.W. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009;9:417-422.


Media Contact
Andrea Sampson, Sullivan & Associates

Erin Manning, Vice President, Marketing, Verrix

TRIA Orthopedics First in Minnesota to Test Breakthrough GelrinC™ Implant to Regenerate Knee Cartilage

November 27, 2018

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

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

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

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

About GelrinC™

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

About the SAGE Clinical Trial

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

About Regentis Biomaterials

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

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


For media inquiries, please contact:
Joni Ramirez
Merryman Communications

Annelise Heitkamp
TRIA Orthopedics

Osiris Therapeutics, Inc. Appoints Samson Tom, PhD, MBA to Serve as President and Chief Executive Officer

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

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

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

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

About Osiris Therapeutics

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

Forward-Looking Statements

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

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

FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to modernize FDA’s 510(k) program

November 26, 2018 / FDA Statement

Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews. We’re pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology. The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging. The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.

We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria. At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge.

We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.

The 510(k) process allows the FDA to recognize that medical devices exist across a continuum of complexity and risk and that the scope of premarket review should reflect this risk continuum. This is a contemporary approach to regulation. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes, wouldn’t be efficient in advancing beneficial new technologies to patients, and wouldn’t allow the FDA to effectively prioritize its scientific resources.

Congress’s creation of the 510(k) process was a paradigm shift from the FDA’s regulation of drugs. It recognized the distinct challenges of regulating such a broad, diverse group of medical products. Today, the FDA regulates more than 190,000 distinct devices. Although the regulatory approach to devices is different than for drugs, the public health objective – assuring that all medical products meet the FDA’s standards for safety and effectiveness – is the same.

The 510(k) pathway represents a more contemporary approach to the risk-based regulation of medical products, but this doesn’t mean the pathway is perfect or not in need of change.

The staff of the FDA’s Center for Devices and Radiological Health (CDRH) has leveraged this risk-based paradigm to develop innovative and forward-leaning regulatory policy that meets our gold standard for safety and effectiveness. In recent months, we’ve taken many new steps to advance these goals. Many of these efforts aim at adopting a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances.

Some of the recent innovative policies include efforts to promote the use of real world evidence in regulatory decision-making; to modernize the De-Novo pathway for low to moderate risk novel devices; to enable the use of rigorous, consensus objective criteria to serve as a predicate for future clearances; to build a national patient safety net; to re-envision a regulatory paradigm for digital health products and in vitro diagnostics; and to chart a premarket review path for breakthrough products. At the same time, we’ve also advanced pathways that can help enable timely patient access to new, innovative and potentially transformative medical devices to help safely treat devastating diseases. For instance, we’ve promoted new ways to safely advance medical devices to diagnose cancer, repair damaged hearts and manage diabetes.

Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.

That’s why, this past April, FDA issued its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. We recognized that there were opportunities for us to continue to enhance our programs to help improve device safety. Our policy ideas spanned the life cycle for devices, including ways to drive innovation of safer devices premarket, and enhance post market patient safety. We’ve made significant progress to advance that plan.

Modernizing the 510(k) Pathway

As part of the Safety Action Plan, we committed to strengthen and modernize the 510(k) program. This is a pathway used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device.

FDA’s 510(k) program is the most commonly used device premarket review pathway. In 2017, CDRH cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved. The 510(k) program has been strengthened and refined in many ways. This has been especially true in recent years, as CDRH made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

Today, following the close of the public comment period and our review of the feedback on the Safety Action Plan, we’re announcing new steps and proposed actions to substantially build on these efforts. We’re focusing on new policy efforts that we plan to advance to help the 510(k) program keep pace with innovation, promote modern patient care and match our evolving understanding of benefits and risks. Our new plans are aimed at continuing to ensure that new and existing devices meet our gold standard for safety and effectiveness as technology rapidly advances.

The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.

In the 510(k) pathway, manufacturers generally rely on comparative testing against predicate devices to show that a new device is as safe and effective as the predicate device. Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates. To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.