SI-BONE, Inc. Announces 50th Peer-Reviewed Publication for the iFuse Implant System® and 25,000th iFuse Procedure

Posted On April 4, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., April 3, 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, announced that the highly respected journal Spine has published the 50^th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis¹. Compared to analyses performed in individual trials, pooling data from these three trials allowed a more statistically powerful determination of patient factors that could predict clinical outcomes after either surgery or non-surgical treatment for appropriately diagnosed patients with SI joint dysfunction.

The pooled analysis study included 423 patients from the three combined multicenter prospective trials, two of which were randomized controlled trials, in which 97 patients received non-surgical management (“NSM”) and 326 patients received SI joint fusion with the iFuse Implant™ from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were much higher in the iFuse Implant group compared to the NSM group. In the NSM group, there were no predictors of improved outcomes. In contrast, in the iFuse Implant group, smoking and opioid use were predictive of somewhat smaller improvements in pain relief and disability whereas higher patient age and longer duration of pain were predictive of larger improvements. Although statistically significant, the difference in treatment responses in these groups were clinically unimportant; that is, all subgroups had clinically large improvements after SI joint fusion with iFuse Implants.

“These results indicate that SI joint fusion with triangular iFuse Implants leads to better treatment outcomes compared to non-surgical management and that the extent of improvement with SI joint fusion is only modestly associated with smoking, opioid use, patient age and duration of pain,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE and study co-author. “Some surgeons do not offer some treatments to smokers or opioid users; for SI joint fusion with iFuse Implants, however, smokers and opioid users had marked and clinically important responses.”

The company also announced that the iFuse Implant System has been used in more than 25,000 procedures worldwide and continues to be the Method of Choice for SI Joint Fusion^SM. Adoption of the iFuse Procedure™ has continued to grow as surgeons learn to include the SI joint as part of their routine low back pain diagnostic exam and insurance coverage for the procedure has expanded. Recently, Healthcare Service Corporation (HCSC), the 4^th largest commercial health plan in the U.S., established an exclusive coverage policy for iFuse for Blue Cross Blue Shield participants in Texas, Illinois, Montana, New Mexico and Oklahoma.

“These are two remarkable milestones that were made possible with over eight years of relentless dedication by our organization and thousands of health care providers who manage patients with SI joint disorders,” said Jeffrey Dunn, President and CEO of SI-BONE. “Together, we have raised awareness and educated thousands on SI joint diagnosis and treatment and with continued focus on education and clinical evidence, we are hopeful that all those suffering from chronic SI joint dysfunction who fail conservative care are able to obtain the appropriate therapy to help them.”

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 (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

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 triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth², facilitating long-term fusion of the joint. The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

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

Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA, SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint: A Pooled Analysis. Spine. Published Ahead-of-Print March 27, 2017. doi:10.1097/BRS.0000000000002169
MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. 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. [Accepted, publication pending]

SOURCE SI-BONE, Inc.

Planned Transfer of Implanet SA’s Listing to Alternext Market in Paris

Posted On April 3, 2017 By OrthoSpineNews In Financial /

April 03, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces that the planned transfer of the listing of its shares from the Euronext regulated market in Paris (compartment C) to the Alternext Paris multilateral trading facility will be submitted to the Shareholders’ Meeting of May 5, 2017 for approval.

The project will allow Implanet to be listed on a more appropriate market for the Group’s size, offering a better regulatory framework and suited to small and midcaps, the market capitalization of the company being approximately € 18 million with a free float of 90%. This planned transfer to Alternext Paris should simplify its administrative burden and reduce its listing costs while providing continued financial market access.

Subject to this project’s approval by shareholders at the upcoming Shareholders’ Meeting, and the consent of Euronext Paris SA, this listing will be carried out via the fast-track admission to trading of the Company’s existing shares without any new shares being issued.

Within the framework of its transfer to Alternext Paris, SwissLife Banque Privée will be Implanet listing sponsor.

In accordance with current regulatory requirements, Implanet would like to inform its shareholders of the possible consequences of a transfer:

In terms of protecting minority shareholders (non exhaustive list):

the protection of minority shareholders, should control change hands, will be ensured by Alternext Paris through the public offering mechanism, if the 50% threshold is exceeded in terms of capital or voting rights, either directly or indirectly and by one party or jointly;
furthermore, companies listed on Alternext Paris are only duty bound to inform the market, in terms of changes in the shareholding structure, of shareholdings moving above or below 50% and 95% of the company’s capital or voting rights;
however, in accordance with regulatory provisions and for a period of 3 months after its listing is removed from the Euronext regulated market in Paris, Implanet will remain subject to the mandatory public offering system and the continuance of information duties regarding the crossing of thresholds and stated intentions applicable to companies listed on the Euronext regulated market in Paris.

Regarding periodic financial information, less restrictive requirements in terms of financial information, including, and again without claiming to be exhaustive, the following:

extension of the timeframe for publishing half-year results – comprising a balance sheet, a P&L statement and comments regarding this period – to 4 months after the half-year ends;
a chairman’s report on the internal audit and corporate governance is no longer mandatory;
the company can choose which accounting system (French or IFRS) it uses when drawing up its consolidated accounts. However, as the Company’s accounts are already drawn up in IFRS, and in order to ensure transparency vis-à-vis its investors and shareholders, Implanet will continue to apply IFRS.

Being a non-regulated market, the transfer to Alternext Paris could lead to a change in the share’s liquidity versus when it was listed on the Euronext regulated market in Paris. The transfer could also lead certain investors, who prefer issuer shares listed on a regulated market, to divest their Implanet shares.

Lastly, Implanet intends to continue publishing accurate, detailed and honest information, making public any news or information liable to have a significant impact on its share price.

Indicative timetable of the transfer

March 27, 2017				The Board decides to submit the planned transfer of Implanet SA’s listing to Alternext to the Shareholders’ Meeting
April 3, 2017				Information published regarding the planned request for admission (1^st press release)
May 5, 2017				Shareholders’ Meeting to approve the transfer to Alternext Paris
May 9, 2017				Information published regarding the definitive transfer decision (2^nd press release)
July 10, 2017				Decision from Euronext Paris SA to admit shares for trading on Alternext Paris, shares
at the earliest				removed from the Euronext regulated market and first listing on Alternext Paris

Next financial press release: Q1 2017 revenue, on April 18, 2017

Annual general meeting: the combined general meeting of Implanet will be held on May 5, 2017 at 10:00 AM CET at the Company headquarters located Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac, France.

You are invited to participate in the voting of the resolutions. For further information, please send your contact details to the following address: implanet@newcap.eu

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements.

This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba
Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

Osiris Therapeutics Launches Prestige™ Lyotechnology, a Novel Method for Ambient Storage of Living Cells and Tissues

Posted On April 3, 2017 By OrthoSpineNews In Biologics /

COLUMBIA, Md., March 30, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (Pink Sheets:OSIR), a leading regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced today that it has developed cutting edge technology enabling the preservation of living cells and tissues at ambient temperatures.

Historically, cryopreservation was the only available method that allowed for long-term preservation of living cells and tissues. However, cryopreservation requires ultra-low-temperature freezers and dry ice or liquid nitrogen for storage, which limits the widespread use of cellular therapies. To address this limitation, Osiris has developed Prestige™ Lyotechnology. Unlike all other known lyophilization methods, Prestige™ Lyotechnology enables the preservation of living cells within tissues while stored at ambient temperatures. Moreover, the manufacturing of lyopreserved living tissues with Prestige™ Lyotechnology is scalable and can be applied to many different cell and tissue types. Placental products will be the focus of the Company’s first application of Prestige™ Lyotechnology.

“This novel technology developed by Osiris will benefit the entire field of cellular therapies. It is expected to accelerate development, commercialization and widespread use of living cell and tissue therapies,” said Alla Danilkovitch, Chief Scientific Officer at Osiris. “Through more than two decades of basic and clinical research, Osiris has not only defined the science and potential of cellular regenerative therapies, but has also created a body of work, advancing the medical community’s understanding of cellular technology. With the introduction of Prestige™ Lyotechnology, Osiris is bringing these innovative cellular therapies to more patients to address a wide range of unmet medical needs.”

The Osiris’s Prestige™ Lyotechnology is featured in tomorrow’s online publication of Osiris’s profile in the scientific journal Nature (www.nature.com), entitled “Innovation on the shelf: solving the puzzle of live-cell preservation”. The print version of this article will appear in the special annual “MedTech Dealmakers” issue of Nature Medicine, Nature Biotechnology and Nature Reviews Drug Discovery in May. Nature is the world’s most highly cited international, interdisciplinary science journal.

About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a world leader in researching, developing, and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the Company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in wound care, orthopedics, and sports medicine, including Grafix®, Stravix™, BIO4 ™, and Cartiform®. Osiris, Grafix, Stravix and Cartiform are trademarks of Osiris Therapeutics, Inc., and BIO4 is a trademark of Howmedica Osteonics Corp. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding the potential uses of Prestige™ Lyotechnology and the publication of Osiris’s profile in Nature (www.nature.com). Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact:



Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

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Also Made in Mexico: Lifesaving Medical Devices

Posted On March 31, 2017 By OrthoSpineNews In Regulatory /

By SARAH VARNEY, March 31, 2017

TIJUANA, Mexico — The North American Free Trade Agreement has transformed this sprawling border town from gritty party spot to something entirely different: a world capital of medical devices.

Trucks choke boulevards lined with factories, many bearing the names of American-run companies: Medtronic, Hill-Rom, DJO Global and Greatbatch Medical. Inside, Mexican workers churn out millions of medical devices each day, from intravenous bags to artificial respirators, for the global market.

Nearly everyone in America who has a pacemaker — in fact, people all over the world — walks around with parts from here.

When President Trump threatens to redo trade deals and slap steep taxes on imports in an effort to add more manufacturing jobs, he focuses largely on car companies and air-conditioner makers. But the medical devices business makes a particularly revelatory case study of the difficulties of untangling global trade.

America imports about 30 percent of its medical devices and supplies. The trouble is, these jobs are among the most difficult to relocate to the United States. To ensure the safety of products that often end up inside the human body, medical devices are strictly regulated and require lengthy approvals from the Food and Drug Administration and other inspectors.

If the companies do keep major operations outside the country, new taxes on imports would most likely increase the cost of their products — a change that could jolt not only the devices industry in coming years, but also health care nationwide.

Here in Tijuana the factories are bound to stay put for years, at least. During that time, health executives say, a border tax could fracture the industry’s sophisticated global supply chain and force American hospitals to pay more for vital necessities — or worse.

“The real danger is the supplies won’t be available at all,” said Dr. John Jay Shannon, chief executive of the Cook County Health and Hospitals System in Chicago.

American hospitals rely on heaps of bandages and surgical gloves from China, suturing needles and artificial joints from Ireland, and defibrillators and catheters from Mexico. In all, the annual imports of medical devices more than tripled from 2001 to 2016, when it reached $43.9 billion, according to BMI Research, a unit of the Fitch Group.

Mexico is the leading supplier, ahead of Ireland, Germany and China. And few places illustrate this changing landscape, or help explain the complexity of the industry, as well as Tijuana, 20 miles south of San Diego.

The city houses the highest concentration of Mexico’s medical device firms, 70 percent of which are American-owned, according to the local development group. Companies including Medtronic, CareFusion, DJO Global and Hill-Rom-Welch Allyn — some that have their headquarters just up the road in San Diego — have invested heavily in Tijuana, constructing long, low-slung factories tucked into the hilly terrain. Giant banners hanging from manufacturing plants plead for workers to join them.

READ THE REST HERE

Here’s Why the Best Is Yet to Come for Intuitive Surgical, Inc.

Posted On March 31, 2017 By OrthoSpineNews In Financial, Robotics /

Keith Speights (TMFFishBiz), March 31, 2017

For several years, it looked like Intuitive Surgical (NASDAQ:ISRG) might be past its prime. The robotic surgical system maker’s stock experienced a malaise throughout much of the period between 2012 and late 2015.

Now, however, Intuitive Surgical is on a roll. Its share price is up close to 20% so far in 2017. Could the best be yet to come for Intuitive? I think so.

Trends in its favor

Most people think about the aging of the baby boomer generation as a key demographic trend. And it is. However, millennials (individuals born between 1981 and 1997) have surpassed baby boomers as the largest generation in the U.S. The aging of both groups should benefit Intuitive Surgical.

Hysterectomy ranks as the top surgical procedure performed using Intuitive’s da Vinci robotic surgical system. More than 40% of da Vinci procedures performed in the U.S. last year were hysterectomies. The average age of American women who have hysterectomies is 42. Many in the millennial generation will reach this age in only a few years.

Intuitive Surgical’s second most performed surgical procedure is radical prostatectomy for patients diagnosed with prostate cancer. The average age of American men who are diagnosed with prostate cancer is 66. Some baby boomers have already reached the prime age for developing prostate cancer, but most aren’t quite that old yet.

It’s not just demographic trends that are working in Intuitive Surgical’s favor. The company generated 71% of total revenue in 2016 from recurring sales of instruments, accessories, and services. This percentage has steadily increased in recent years. Intuitive’s huge recurring revenue provides it stability and flexibility that many other companies don’t enjoy.

READ THE REST HERE

Total Joint Center at The Miriam Hospital awarded second Joint Commission Gold Seal of Approval

Posted On March 31, 2017 By OrthoSpineNews In Recon /

PUBLIC RELEASE: 27-MAR-2017 – AAAS and EurekAlert

PROVIDENCE, R.I. – The Total Joint Center at The Miriam Hospital has earned The Joint Commission’s Gold Seal of Approval® for Advanced Certification for Total Hip and Total Knee Replacement. The certification recognizes the Total Joint Center’s quality, consistency and safety of services and patient care set by The Joint Commission.

The Total Joint Center is the only such program in the state and among only three in New England to earn the advanced designation.

“This advanced Joint Commission certification is recognition of The Miriam Hospital’s team approach to ensuring patients have the best possible outcome. This is achieved by providing safe, state-of-the-art care, starting prior to surgery and through the rehabilitative process,” said John A. Froehlich, M.D., program director of the Total Joint Center.

Earlier this month, The Miriam Hospital underwent a rigorous onsite review by the Joint Commission to become one of only 32 advanced total hip and knee centers in the country. Joint Commission experts evaluated compliance with advanced disease-specific care standards and total hip and total knee replacement requirements, including orthopedic consultation, and pre-operative, intraoperative and post-surgical orthopedic surgeon follow-up care.

READ THE REST HERE

SANUWAVE Health to Hold 2016 Financial Results and Business Update Call on Tuesday, April 4, 2017

Posted On March 31, 2017 By OrthoSpineNews In Financial /

SUWANEE, GA–(Marketwired – Mar 31, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) announced today that the Company will release financial results for the year ended December 31, 2016, on April 4, 2017.

The Company will also host a conference call on Tuesday, April 4, 2017, beginning at 10AM Eastern Time to discuss the 2016 financial results, provide a business update and answer questions.

Shareholders and other interested parties can participate in the conference call by dialing 866-682-6100 (U.S.) or 862-255-5401 (international) or via webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175797.

A replay of the conference call will be available beginning two hours after its completion through April 18, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 10303.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Contact:
Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com

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AMNIOX Study Confirms Benefits of CLARIX FLO for Plantar Fasciitis

Posted On March 30, 2017 By OrthoSpineNews In Extremities /

ATLANTA–(BUSINESS WIRE)–

AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today the results of a study demonstrating the application of its unique cryopreserved human umbilical cord tissue for the treatment of patients with plantar fasciitis. The findings were recently presented at the American College of Foot and Ankle Surgeons in Las Vegas.

In this study, forty-three patients received injections of CLARIX FLO human amniotic membrane and umbilical cord matrix, and were followed for 18 weeks. The authors concluded that injections of CLARIX FLO significantly decreased pain from baseline and improved overall functional recovery. Increasing dose resulted in better therapy outcomes.

The study, Particulate Umbilical Cord/Amniotic Membrane for the Treatment of Plantar Fasciitis, was authored by Dr. Ryan Scott of The CORE Institute in Phoenix, and Dr. David Garras of Midwest Orthopaedic Consultants and an Assistant Professor at University of Illinois at Chicago. Plantar fasciitis is the most common cause of debilitating heal pain. It affects up to 1 million patients annually in the United States and as many as 30 percent of those patients fail conservative therapy. The condition is characterized by an accumulation of small tears in the plantar fascia, causing the structure to weaken and become irritated, often to the point of interfering in daily activities. Previously available therapies have demonstrated inconsistent outcomes or have negative side effects.

“These study results continue to demonstrate the compelling therapeutic benefits of a human tissue matrix composed of both umbilical cord and amniotic membrane,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Furthermore, Amniox Medical is the only provider of an injectable form of umbilical cord, allowing for the non-invasive delivery of the biological components of umbilical cord, which have proven regenerative properties.”

In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to placental tissues, including umbilical cord and amniotic membrane. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate the healing process. Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox utilizes its proprietary CryoTek™ process, a cryopreservation technology, to preserve the biological and structural integrity of the native tissue and published studies have demonstrated that the CryoTek process more effectively preserves the structural and biological integrity of the tissue.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue^®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; Bio-Tissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft^®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170330005905/en/

CollPlant Provides Commercial and Operational Update

Posted On March 30, 2017 By OrthoSpineNews In Biologics, Sports Medicine /

NESS ZIONA, Israel, March 30, 2017 /PRNewswire

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), today provided a commercial and operational update in its annual reports.

Most recently, in November 2016, the Company announced the signing of an exclusive distribution agreement with Arthrex GMBH to distribute Vergenix™STR, CollPlant’s CE Mark-approved treatment for tendinopathy, in Europe, and has supplied Arthrex with first orders. Arthrex, an affiliate of Arthrex Inc., based in Naples, FL, is a leading orthopedics company and is widely considered to be the world leader in sports medicine. Additionally, since mid-2016, CollPlant signed a number of marketing agreements for Vergenix™FG, its wound care product, covering Italy, Switzerland and Turkey. Commercial treatments have been completed over several months in Switzerland and Italy, and physicians’ feedback regarding patient results have been very positive.

CollPlant has also reported extensively for the first time on the development of its collagen-based biological ink, bioInk, for use in 3D printing of organs and tissues. Specifically, the Company is developing rhCollagen-based bioInk formulations for indications including skin, orthopedics, ophthalmology, heart and lung. The Company’s goal for the coming year includes working with a strategic international partner to further develop a specific indication of this product.

CollPlant’s Highlights for 2016 and the start of 2017

Vergenix™FG – a wound filler based on the Company’s rhCollagen technology, for treatment of acute and chronic wounds: The product received CE Mark approval and distribution agreements have been signed in Italy, Switzerland and Turkey, including first orders, a portion of which were supplied in 2016. The initial target market for Vergenix™FG is estimated at $500 million annually. The Company has received positive feedback from physicians who have treated patients with the product in Europe.
Vergenix™STR – a gel based on the Company’s rhCollagen technology, indicated for the treatment of tendinopathy: The product was granted CE Mark approval following successful clinical trials, and an exclusive distribution agreement was signed with Arthrex covering Europe, India and Africa. To date, CollPlant has reported on two orders supplied to Arthrex, and the product is currently in the initial stages of penetrating the European market. First treatments have commenced in Europe. The target market for Vergenix™STR is estimated at about three million procedures per annum worldwide, with a value of $2 billion.
BioInk for 3D printing of organs and tissues – the Company is developing a biological ink (bioInk) based on its rhCollagen technology, intended for use with 3D printers, to print tissues and organs. In parallel, the Company is assessing potential joint ventures with international companies to further develop various applications such as skin, bones, ophthalmology, heart and lungs. The Company’s objective for this year is the development of a specific indication in order to achieve the creation of multilayer tissue combined with stem cells and other cells. The segment of 3D printing addresses the entire global medical market.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:
Eran Rotem
Chief Financial Officer
Tel: +972-73-2325600/612
Email: Eran@collplant.com
Contact at Rx Communications Group, LLC
Paula Schwartz (for US Investors)
Senior Vice President
Tel: +1-917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlan

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Restructuring at Stryker will mean ‘limited reductions of workforce’

Posted On March 30, 2017 By OrthoSpineNews In Financial, Top Stories /

By Al Jones | March 29, 2017

PORTAGE, MI — Stryker Instruments division is undergoing an organizational restructuring that will mean a loss of jobs for an undisclosed number of people at the medical technologies company.

“After a thoughtful evaluation, we have determined that organizational changes are needed to help drive efficiencies across our business, including limited reductions in our workforce,” the company stated in a press release issued in response to inquiries Wednesday.

It went on to say, “These changes will allow us to invest in important areas to build new capabilities that will help us keep growing in Kalamazoo and continue meeting the needs of our customers.”

Stryker Instruments designs, manufactures and markets specialty surgical equipment, operating room products, orthopedic saws, drills and accessories. It also make advanced systems for such things as pain management and waste management.

“The Kalamazoo community has played an important role in our company’s history,” the company stated. “Our founder started the business here and today we have multiple manufacturing and corporate offices in the area. We are committed to strengthening that relationship through our upcoming expansion in Portage.”

Portage Mayor Peter Strazdas said he has not been told how many people will be affected by the restructuring and he hopes the company is working to find them other opportunities. But he said he understands that large corporations have ups and downs and hopes internal changes will help make Stryker a stronger company in the long run.

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Author: OrthoSpineNews

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