Regulatory – Page 28

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June 16, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, a data-driven digital portal for the Company’s Adaptive Spine Intelligence.

“It is our belief that data science and analytics are critical components of improved patient outcomes and efficiencies. For that reason, Medicrea has stepped into a space unoccupied by traditional device manufacturers: Software development and Artificial Intelligence,” stated Denys Sournac, President and CEO of Medicrea. “The UNiD™ HUB represents Medicrea’s ability to lead the Spine industry with breakthrough innovations by offering a unique forward-thinking and holistic approach to personalized spinal surgery.”

The UNiD™ HUB is designed to support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery. The UNiD™ HUB software also serves to enhance the existing proprietary IT utilized by Medicrea’s UNiD™ ASI platform for digital surgical planning to create a seamless communication channel between the Company’s UNiD™ LAB biomedical engineers and Surgeon users to deliver UNiD™ TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3D printing techniques.

The digital communication portal opened with the introduction of UNiD™ HUB instantly creates a sticky, user-friendly environment for surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses and dialogue with a dedicated biomedical engineer in real time. Future functionalities will become available alongside the software’s wide release planned in October of 2017, for Eurospine in Dublin, Ireland on the 11-13 October and at the annual meeting of the North American Spine Society, held 25-28 October in Orlando, Florida.

Mr. Sournac continued, “As a media tool for surgeons, we have received very positive feedback from our UNiD™ ASI customers who have seen beta versions of the software and we are now ready to make the UNiD™ HUB digital portal immediately available to them. The software integrates well with their clinical habits and enhances their experience with UNiD™ ASI technology.” Mr. Sournac added, “This new generation of software will be more than a communication tool for surgeons – It will grant surgeons access to the same data analytics and machine learning technology that is curated by our data scientists to use the UNiD™ HUB as an unparalleled research engine and networking platform.”

UNiD™ HUB has been developed in desktop and mobile applications and is accessible from medical offices as well as on the go. For a first look at the UNiD™ HUB, a video preview is available for viewing here.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

By leveraging its proprietary software analysis tools with big data and machine learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on ALTERNEXT Paris ISIN: FR 0004178572 Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87

WARSAW, Ind., June 13, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility has been closed out.

“The successful clearance of the Warning Letter related to our Zhejiang, China manufacturing facility is a measure of the progress we have made in our ongoing quality and operational excellence journey,” said David Dvorak, Zimmer Biomet’s President and Chief Executive Officer. “Zimmer Biomet takes seriously its responsibility to support surgeons and their patients, and the Company will continue to take the necessary actions to demonstrate our commitment to quality excellence, patient safety and regulatory compliance.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

Alicia Stice and Jacy Marmaduke , Coloradoan – June 8, 2017

Last year, Dr. Kenneth Pettine was arrested on a handful of charges related to prescription fraud. Now, he can never practice medicine again. The Coloradoan takes you inside the investigation.

In hindsight, Sherri Kaspar feels weird about the Fudgsicles.

Nationally renowned spinal surgeon Kenneth Pettine bought them for her after he performed a procedure that Kaspar said left her without use of her legs and triggered relentless, debilitating infection.

Pettine stowed the treats in a freezer at McKee Medical Center in Loveland, scrawling her name on the box he bought for her to enjoy post-surgery.

Kaspar used to think the gesture meant Pettine was her friend. Now that Pettine is a convicted criminal barred from practicing medicine, she considers the ice cream a symbol of the doctor’s knack for manipulation.

“He tried to buy me off,” she said during an interview at her Kersey mobile home.

That incident was a long time ago — 26 years ago, to be exact. But Kaspar’s experiences illustrate the two vastly different versions of the Johnstown surgeon arrested in June 2016 on suspicion of prescription fraud.

Pettine’s supporters paint him as a man of faith, an Eagle Scout, a brilliant surgeon with “hands of gold” who financed college educations and saved children from disease and neglect with his own money.

Others describe a darker side of Pettine: A drug-addled smooth-talker who botched surgeries, lied on medical records and used his position of power to secure an endless stream of prescription drugs. Several former patients said they went to Pettine for help and emerged from surgeries in excruciating pain, suffering from mistreated infections and lifelong disabilities.

Maybe you saw Pettine in the news last year. It was a big story.

On May 2, 2016, Kenneth Pettine was a well-regarded figure in the medical field who’d performed 12,000 spinal surgeries. He had a $2.4 million mansion and ownership stakes in three medical practices and a surgical center.

Then his minority partners at Johnstown’s Premier Regenerative Stem Cell and Wellness Centers turned him in. The criminal investigation that followed left Pettine stripped of his medical license and saddled with lawsuits and misdemeanor convictions.

READ THE REST HERE

SAN JOSE, Calif., June 13, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced FDA clearance and full U.S. commercial launch of the iFuse-3D™ Implant (“iFuse-3D”), the first-ever 3D-printed titanium implant for use in the SI joint. SI-BONE developed a proprietary 3D-printing technology to create an implant with a unique patented fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. Together, these two features provide an excellent environment for bony ongrowth, ingrowth and through growth¹.

iFuse-3D leverages the clinically proven triangular titanium design of the iFuse Implant™ that is supported by more than 50 peer-reviewed publications and has been used in over 26,000 procedures since 2009.

The iFuse-3D Implant’s surface and fenestrated structure were designed to provide enhanced osteointegration and promote intra-articular fusion. A study, published on June 1, 2017, in the International Journal of Spine Surgery (IJSS) titled: Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants¹ shows significant bone growth on and into the implant’s porous surface (Figure 1) as well as through its fenestrations (Figure 2).

Scott Yerby, Chief Technology Officer at SI-BONE, commented, “The design and development of the iFuse-3D implant was a multi-year effort. Our goal was to expand the iFuse family using 3D-printing technology to provide enhanced surface characteristics while retaining key performance features of the iFuse Implant, including superior rotational resistance, mechanical strength and ease of use with our existing instrumentation. iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than our highly successful iFuse Implant. Additionally, the structural fenestrations allow complete bone through growth.”

“The iFuse-3D Implant embodies our commitment to advancing the diagnosis and treatment of chronic SI joint disorders through innovative products, procedures and educational programs in order to help patients suffering from chronic SI joint pain,” said Jeffrey Dunn, President and CEO of SI-BONE. “Our team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the iFuse Implant, and we believe that expanding the iFuse family has the potential to help thousands more patients. What can be more exciting and rewarding than that?”

On May 30, 2017, the U.S. Patent and Trademark Office issued patent no. 9,662,157 covering various structural design features of the iFuse-3D Implant that will extend intellectual property protection of the unique implant design for 17 years until September 2035.

About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁶ Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.

SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it. While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test. The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.

About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The patented triangular implant shape and patented press fit insertion technique are designed to provide immediate fixation by minimizing the SI joint’s unique motion called nutation. The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth¹, facilitating long-term fusion of the joint. The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.

The iFuse Implant System^® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.

MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.
Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

first-vertera-spine-peek-cohere-cervical-fusion-devices-successfully-implanted.jpg

ATLANTA, June 13, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10 code for a radiolucent porous interbody fusion device. The new classification will enable healthcare providers and payers to selectively track the utilization, outcomes and healthcare costs associated with this unique technology class. Vertera Spine’s COHERE Cervical Interbody Fusion Device is the first and only clinically-available porous fusion device manufactured out of the radiolucent plastic polyether ether ketone (PEEK), and is approved for use under the new code. The IDC-10 code is effective October 1, 2017 as an XRG code and listed as “Interbody Fusion Device, Radiolucent Porous.”

Spinal interbody fusion devices have traditionally been classified by the implant material, either synthetic or tissue-derived alternative (e.g. autograft and allograft). However, as more advanced orthopedic biomaterials are developed, the use of a single coding identifier for all synthetic devices may no longer be appropriate for accurately describing fusion procedures. Five years of basic science, preclinical and clinical research^1-3 have shown that porous PEEK possesses several performance characteristics that distinguish it from other fusion devices by combining the osseointegration capabilities of porous metallic devices with the favorable imaging properties of non-porous plastic devices. This valuable combination of device attributes was introduced with FDA clearance of the COHERE device, prompting the issuance of the new ICD-10 code by CMS.

In addition to serving as a tracking method for healthcare payers and providers, the ICD-10 code can also potentially benefit spine surgeons in clearly identifying the best options for patients.

“The issuance of this new code signifies the unique performance of porous PEEK devices compared with other fusion devices and the importance of monitoring how this technology impacts healthcare,” said Richard Guyer, M.D., Texas Back Institute. “As a clinician, I am always looking for innovative technologies, such as Vertera Spine’s porous PEEK COHERE device, that have the potential to improve patient outcomes.”

As stated by Kevin Foley, M.D., Semmes-Murphey Neurologic and Spine Institute:

“The development of porous PEEK has allowed for the combination of radiolucency and porosity in an interbody implant that is completely plastic. In vivo studies have demonstrated that bone will grow into porous implants, improving their osseointegration. Until now, the only porous implants clinically available were made of metal or had a metallic coating, which can limit the surgeon’s ability to assess fusion on imaging. This new code gives us the potential to better correlate bony tissue ingrowth into Vertera Spine’s porous PEEK COHERE device with clinical outcomes.”

Likewise, Erik Westerlund, M.D., St. Francis Spine Center, and an early adopter of Vertera Spine’s COHERE device, shared similar sentiments:

“I began to see my one year follow-up COHERE device patients in May of this year and the results have shown a clear and consistent trend of rapid and readily visible progression to robust osseous union. Not only is there characteristic radiographically visible osseous incorporation at the interconnected porous margin of the COHERE PEEK spacers, there is also a notable continuity of bridging bone across the entire interspace. The grant of a new specific ICD-10 code for porous PEEK will provide myself and other spine surgeons greatly refined capacity to track clinical outcomes and cost savings with this genuinely transformational class of porous PEEK interbody spacers like Vertera Spine’s COHERE.”

With its first clinical use in Q2 of 2016, COHERE is the first device featuring Vertera Spine’s patented porous PEEK biomaterial technology. Intended for use in anterior cervical fusion surgery, COHERE contains a three-dimensional porous architecture on its bone-contacting sides that is specifically designed and optimized to promote cellular bone formation and effectively form a strong interface with bone. Unlike some porous treatments that are coated onto the device, COHERE’s porous architecture is grown directly from the solid PEEK implant using a proprietary processing method that allows for bone tissue ingrowth on the surface, while retaining strength and durability.

“We are excited that CMS has adopted a new code for radiolucent porous devices and are pleased that COHERE will fall under this designation,” said Chris Lee. Ph.D., founder and CEO of Vertera Spine. “The availability of a radiolucent porous fusion device means that for the first time, bone tissue ingrowth can potentially be assessed into the device. This will allow us to further understand the role of implant integration with clinical outcomes.”

¹Smith KE, et al. Techniques in Orthopaedics, 2017 (accepted in press).
²Torstrick FB, et al. CORR, 2016; 474(11): 2373-2383.
³Evans NT, et al. Acta Biomaterialia, 2015; 13: 159-167.

About Vertera Spine:

Vertera Spine is a privately-held medical device company that develops, markets and sells implants that use or complement its patented porous technology to address critical clinical needs in spine surgery. The company has received funding from the National Science Foundation, Georgia Research Alliance and Duke Angel Network to translate its growing technology portfolio into commercial products. For more information, visit www.verteraspine.com or call 678.705.9039.

COHERE is a registered trademark of Vertera Spine. All other trademarks and trade names are the property of their respective holders.

SOURCE Vertera Spine

06 Jun 17

Kuros (SIX:KURN) today announced it has filed the submission package for MagnetOs Putty seeking 510(k) clearance from the US Food and Drug Administration (FDA) for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to support bone healing in the implanted site in the body. MagnetOs Putty is a moldable putty formulation of MagnetOs Granules, which is already cleared for commercialization in the United States of America and the European Union.

Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA filing is yet another important milestone for Kuros as it eventually expands our portfolio of commercial-stage products. A similar submission for MagnetOs Putty in the EU will be filed in the next months.” He continued: “MagnetOs features a unique surface science technology that supports local bone formation. To meet surgeons’ preferences, we are developing a comprehensive product line consisting of different formulations and applications of MagnetOs. Furthermore, we plan to extend the existing labels into additional indications.”

MagnetOs Putty advantage

According to Kuros estimates, there are over 3 million procedures worldwide each year that use a bone graft material or a substitute. Patient-own bone (autograft) is still considered the gold standard bone grafting material. However, harvesting healthy bone usually requires a separate surgical procedure with associated costs, risks and morbidity. Therefore, an extender that can be used in combination with local autograft, without the need for a separate autograft harvest procedure, offers significant potential benefits. Animal testing demonstrates comparable rates of bone healing for MagnetOs when used as an extender with autograft compared to autograft alone in a rabbit posterolateral fusion model.

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel: +41 79 750 15 64

harry.welten@kuros.ch

About Kuros Biosciences Ltd

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This news 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.

OR AKIVA, Israel, June 5, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced CE mark of the FLXfit™15, enhancing the already successful FLXfit™ 3D expandable cage. The FLXfit™15 expands up to 4mm and enables controlled lordosis correction of up to 15⁰. There are two linear length options; a 40mm and a 32mm version.

The higher range expansion will enable surgeons to better treat their patients and restore lordosis angle up to 15⁰. The 32mm length option will offer great flexibility in treating patients with smaller anatomies. The ability to deliver the largest, in-class, TLIF, expandable cage with 4mm height expansion and 15 degrees of lordosis correction through a small unilateral tube is a paradigm change in the MIS fusion market.

Ofer Bokobza, CEO of Expanding Orthopedics, commented “Expandable cages are gaining market momentum and play a key role in successful MIS fusion procedures. The FLXfit™ 3D expandable cage introduced a new paradigm with expandable cages and is already making a significant traction in the market place. We are thrilled with the release of the FLXfit™15 as it represents our continued commitment for innovation and ability to deliver state-of-the-art spine fusion solutions.” He concluded, “We believe that the versatility of the new FLXfit™ family will help EOI gain a greater share in the fusion surgery market both in MIS and open approaches.”

The FLXfit™15 is the subject of a pending 510k and is not available for sale in the US.

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.
Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-3219683

SOURCE Expanding Orthopedics Inc.

Warren, NJ, June 01, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it has received FDA 510(k) clearance of FIBERGRAFT BG Putty – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Putty is the second generation product in the company’s FIBERGRAFT line of bioactive glass based products. FIBERGRAFT BG Putty leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary bioactive carrier, OSSIGLIDE.

FIBERGRAFT BG Putty – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Dr. Babak Barcohana MD of the Southern California Orthopedic Institute commented, “I have had outstanding clinical results with FIBERGRAFT BG Morsels over the last three years and look forward to continued clinical success with this next generation product from Prosidyan.”

Dr. Stephen Tolhurst MD of the Texas Back Institute commented, “FIBERGRAFT BG Putty is backed by great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”

Dr. Brian Kwon MD from New England Baptist Hospital called FIBERGRAFT BG Putty “The most intelligent bone graft on the market and your best bone graft decision in the OR.”

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 7,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.

Contact Information

Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com

May 31, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (“Orthocell or Company”) is pleased to announce it has received confirmation from the Therapeutic Goods Administration (TGA) that Ortho-ACI® has been included on the Australian Register of Therapeutic Goods (ARTG).

Orthocell’s Autologous Chondrocyte Implantation (Ortho-ACI®) for cartilage repair and regeneration has previously been approved for sale in Australia pursuant to a TGA issued manufacturing license, but in order to maintain regulatory approval in Australia for the commercial sale of Ortho-ACI® pursuant to the relevant transitional provisions, Orthocell had lodged an application for approval and inclusion on the ARTG.

Inclusion on the ARTG marks a significant milestone for the Company enabling the commencement of the process for reimbursement and also the wider sale and distribution of Ortho-ACI® for cartilage repair and regeneration within Australia and the treatment of patients in other countries such as Hong Kong, Singapore and New Zealand. This milestone also represents the first cell therapy for cartilage repair to be included on the ARTG.

Ortho-ACI® is the gold standard intervention for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. Damage to articular cartilage can occur through injury or normal wear and tear. When articular cartilage is damaged, it does not repair itself effectively like other tissues and cartilage defects lead to increasing joint pain and impaired mobility, which affects activities of daily living and exercise. These defects present a difficult clinical problem and if left untreated can lead to osteoarthritis.

Ortho-ACI® provides the opportunity for the body to regenerate its own cartilage and provide a functional and durable outcome. Orthocell has treated patients in Australia, Hong Kong and Singapore. Ortho-ACI® is indicated as a pre-arthritis cell therapy that is designed to treat the localized defects in the knee, patella and ankle that can lead to osteoarthritis and cartilage degeneration

Orthocell Managing Director Paul Anderson said “the inclusion by the TGA of Ortho-ACI® on the ARTG is a significant milestone for the Company and enables the continued pathway towards reimbursement.”

About Orthocell Limited

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro®, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.

For more information on Orthocell, please visit www.orthocell.com.au or follow us on Twitter @Orthocellltd and Linkedin www.linkedin.com/company/orthocell-ltd

Contacts

General enquiries
Orthocell Limited
Paul Anderson, +61 8 9360 2888
Managing Director
paulanderson@orthocell.com.au
or
Investor and Media enquiries
WE Buchan
Ben Walsh, +61 411 520 012
bwalsh@buchanwe.com.au

May 26, 2017

BREDA, Netherlands–(BUSINESS WIRE)–Freedom Neuro BV, a medical device distributor for Stimwave Technologies Incorporated, today announced CE Mark approval for the world’s first Percutaneous Injectable Anchor System. The injectable anchor is utilized in conjunction with the company’s wireless neurostimulator devices to provide true innovation in fixating Stimwave’s Wireless Pain Relief^®technology through a minimally-invasive outpatient procedure for those who suffer from chronic pain.

“A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best in customization for patients to manage their pain profiles,” said Bart Billet, MD, from AZ Delta hospital group in Roeselare, Belgium.

Once the stimulator is injected, the SandShark is slid down over the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician pulls back on the handle, simultaneously deploying the wings of the anchor and pushing them laterally into the tissue. This injection process secures the anchor to the stimulator and secures the stimulator to the surrounding tissue to prevent migration throughout the life of the micro-implant. The injectable anchor stays in line with the body’s nerves, allowing for a freedom of movement generally not available in other neuromodulation devices.

“The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators.”

Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices use Wireless Pain Relief^®technology, are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The CE Marked Freedom-8A SCS System can provide European patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief.

For more information, visit www.stimwave.com.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

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