Carevature Medical Announces Pioneering Cervical Spinal Decompressions in the US

TEL AVIV, Israel, June 12, 2017 /PRNewswire/ — Carevature Medical Ltd., developer of advanced orthopedic surgery solutions, announced today the first cervical decompression cases using its proprietary Dreal™ system in the US. The procedures were performed by Dr. John Peloza of the Center for Spine Care, Dallas, TX.

Dr. Peloza, a world-renowned orthopedic surgeon specializing in advanced minimally invasive spine technologies, has been using the Dreal™ system continuously since late 2016. Dr. Peloza has successfully performed over 40 lumbar procedures at the Baylor Scott and White Medical Center, Frisco, TX, before employing the Dreal™ system in cervical spinal decompression for the first time in the US.  The cervical cases included posterior decompressions, in which Dr. Peloza was able to perform a bilateral C4-5 foraminotomy through a small laminotomy opening; and ACDF and corpectomy procedures, where he was able to safely remove osteophytes from the posterior part of the vertebral bodies of the levels treated.

Using the Dreal™ system enabled Dr. Peloza to effectively decompress the spinal nerves with minimal damage to surrounding tissue, while maintaining a high safety profile.

“I was introduced to Dreal™ long before the system’s US approval, and was eager to start using it with my patients”, says Dr. Peloza. “The Dreal™ system fits with my philosophy: preserving as much healthy tissue as possible, making these procedures shorter and safer – and most importantly, improving patient recovery. This system is intuitive, it’s easy to use, and it has become an integral tool that I’ve been using in a growing number of spinal decompressions”.

“These cases demonstrate the huge commercial potential of the Dreal™ system”, says Robert (Bob) W. Cook, a seasoned spine industry executive, recently appointed as Carevture’s VP Marketing and Sales. “while innovative tools have been introduced for lumbar decompression, no other solution brings Dreal™’s ability to effectively decompress the entire spine, with minimum trauma and maximum safety”.

About Carevature

Carevature Medical Ltd., a privately-held medical device company headquartered in Rehovot, Israel, is dedicated to developing advanced orthopedic surgery solutions.

Carevature is presently focused on its flagship line of products for spinal indications, Dreal™, the first and only curved device powerful enough to efficiently cut bone, and small enough for use in all sections of the spine.

Over 450 patients worldwide have been treated with the Dreal™ in clinical and commercial cases, with outstanding safety and recovery results.

Find out more: http://www.carevature.com

Media contact person:
Robert W. Cook, Vice President, Marketing & Sales
M: 260-417-1643
E: bob@carevature.com

 

SOURCE Carevature Medical Ltd.

Exactech Expands Presence in Japan with Newly Approved Shoulder, Knee and Hip Replacement Systems

June 22, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that the company marked the first clinical use of recently approved shoulder, knee and hip replacement systems in Japan this quarter. These surgeries coincide with the series of new product introductions the company has reported in the U.S.

Exactech has gained regulatory approval to introduce additional products from each of its three major product segments to the Japanese market. The first Optetrak Logic® CR knee system was implanted on April 6 at Taketa Medical Association Hospital in Oita. The Novation® Crown Cup acetabular component debuted on April 26 in Ukubo City. The first Exactech total hip replacement surgery in Japan took place on May 16 at the Taketa Medical Association Hospital when a surgeon implanted the Alteon Tapered Wedge Stem along with the Crown Cup. The first Equinoxe Reverse Shoulder system was implanted June 5 at Sano Memorial Hospital.

“Exactech has maintained direct distribution in Japan since 2008 with consistent growth. These new product introductions are important milestones for Exactech in one of our key global markets,” said Exactech Vice President of International Sales and Market Development Daniel Berdat. “We are pleased to expand our offerings with these important innovations to better serve surgeons and patients.”

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Exactech
Media contacts
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

K2M First-to-Market with 3D-Printed Expandable Interbody System Following FDA Clearance of MOJAVE™ PL 3D

LEESBURG, Va., June 22, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced that its MOJAVE™ PL 3D Expandable Interbody System has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). MOJAVE PL 3D is a first-to-market, FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody system that features K2M’s Lamellar 3D Titanium Technology™. K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices.

The MOJAVE PL 3D Expandable Interbody System is a fusion device designed to allow for independent control of the anterior and posterior height in the lumbar spine, a new capability not available with any other product in the market today. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

“The ability to provide independent control of both the anterior and posterior height separately is desirable for the restoration of sagittal balance compared to existing devices that can’t independently adjust both anterior and posterior height,” said Steven Ludwig, MD, an orthopedic spine surgeon and professor of orthopedics at the University of Maryland Medical Center in Baltimore.

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE PL 3D endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D Titanium Technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the endplates.

“We are proud to be the global leader in 3D printing of spinal applications. We have developed internal 3D expertise that is allowing us to accelerate the rate of spinal innovation. As the first-ever, FDA-cleared, 3D-printed expandable interbody technology, MOJAVE PL 3D exemplifies our leadership in this space and provides surgeons the ability to expand the implant in-situ. This is our second family of products featuring Lamellar 3D Titanium Technology and builds upon the incredibly successful CASCADIA™ 3D family of static 3D-printed interbody cages,” said K2M President and CEO Eric Major. “Our continued innovation in 3D solutions and our focus on 3D spinal balance, demonstrated by the recent launch of our Balance ACS™ platform, solidifies our position as a market leader and innovator in the industry. We look forward to continuing to introduce new three-dimensional solutions to surgeons who treat patients with spinal disorders.”

Balance ACS (BACS) is a comprehensive platform applying three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes in spine patients. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

For more information about the MOJAVE PL 3D Expandable Interbody System and Lamellar 3D Titanium Technology, visit www.K2M.com. For more information about K2M’s Balance ACS platform, visit www.BACS.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

 

Media Contact:
Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com 

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

Senate Health Care Bill Includes Deep Cuts to Medicaid

WASHINGTON — Senate Republicans, who have promised a repeal of the Affordable Care Act for seven years, took a major step on Thursday toward that goal, unveiling a bill to cut Medicaid deeply and end the health law’s mandate that most Americans have health insurance.

The 142-page bill would create a new system of federal tax credits to help people buy health insurance, while offering states the ability to drop many of the benefits required by the Affordable Care Act, like maternity care, emergency services and mental health treatment.

The Senate bill — once promised as a top-to-bottom revamp of the health bill passed by the House last month — instead maintains its structure, with modest adjustments. The Senate version is, in some respects, more moderate than the House bill, offering more financial assistance to some lower-income people to help them defray the rapidly rising cost of private health insurance.

But the Senate measure, like the House bill, would phase out the extra money that the federal government has provided to states as an incentive to expand eligibility for Medicaid. And like the House measure, it would put the entire Medicaid program on a budget, ending the open-ended entitlement that now exists.

It would also repeal virtually all the tax increases imposed by the Affordable Care Act to pay for itself, in effect handing a broad tax cut to the affluent, paid for by billions of dollars sliced from Medicaid, a health care program that serves one in five Americans, not only the poor but almost two-thirds of those in nursing homes. The bill, drafted in secret, is likely to come to the Senate floor next week, and could come to a vote after 20 hours of debate.

READ THE REST HERE

New Oska® Pulse Shows to Reduce Pain in Pilot Clinical Study

CARLSBAD, CA – June 13, 2017 – Oska Wellness, a technology company committed to developing consumer health and wellness products, has released a third-party, independent study showing significant results that Oska Pulse can reduce pain and improve mobility in a phase I clinical trial. Oska Pulse is a safe, easy-to-use, portable and wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

The study was authored by Dr. Kathy Davis, Associate Professor of Nrsing at Gordon State College, Ga. and published by Dr. Mark D. Wiederhold, Chief Executive Officer at the Virtual Reality Medical Center at Scripps Memorial Hospital in La Jolla, Ca.

The findings were published in Journal of Pain Management (volume 10, issue 2) and suggest that Oska Pulse is a very effective method in managing pain relief. Journal of Pain Management is a peer-reviewed, open access journal that publishes original research articles, review articles, and clinical studies in all areas of pain management.

Of the preliminary results, the most promising findings include:

  • 80% of participants experienced an improvement in pain reduction
  • 40% reported a perceived improvement in overall mobility
  • 30% of the total participants remained pain-free or nearly pain-free for the duration of the four week trial

“I think this is a good initial report with solid results – especially with helping mobility,” said Dr. Davis. “With chronic pain as a common problem seen in clinical practice, patients and providers are seeking alternatives to pain management that are safe and effective.  It is critical to continue to study the device with larger samples of the population to further evaluate the full potential of Oska Pulse.”

“We are excited for the people living with chronic and acute pain to have access to new data supporting the use of non-drug, noninvasive pain-relief technology as demonstrated in this study,” said Greg Houlgate, CEO/President Oska Wellness.  “We are committed to helping people return to an active lifestyle without the use of drugs or other invasive techniques.”

Oska Pulse, with proprietary eTec™ Pulse Technology, is a small, portable, hands-free wearable device that safely optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help people live a more active, pain-free and drug-free lifestyle.

Additional research has shown that PEMF signals pass through bone and other tissue to aid the body in delivering more nutrients and oxygen to tissues while removing waste products. The Oska Pulse’s “Sequential Protocol Programming” delivers four frequencies specifically related to muscle relaxation, bone tissue circulation, capillary dilation and pain reduction.

By helping to release the body’s natural endorphins, the Oska Pulse helps reduce pain and promotes increased range of motion. By dilating blood vessels, it reduces inflammation and the increased oxygen rich blood flow speeds muscle recovery.

About Oska Wellness 
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition.

 

ADD COUPON CODE  “ORTHOSPINECO”  FOR  $55.00 OFF

READ MORE ABOUT OSKA HERE

 

The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

 

 

 

 

Implanet announces the commercial launch of the new JAZZ™ braid in Europe and the United States

June 22, 2017

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

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has obtained marketing clearance from the U.S. and European regulatory authorities to market its new JAZZ™ braid.

The new JAZZ™ braid is an improved version, designed in response to surgeon feedback since initial launch in late 2013. Technical characteristics have been optimized, with part of the band now ultrasonically bonded, further improving the Band’s handling and stability. Compatible with the current instrument system, the braid will continue to interface with the proprietary JAZZ tensioning system.

Innovation is a key driver of Implanet’s development strategy. With this in mind, and in order to continually meet the requirements of the surgical community, we are launching an optimized version of the JAZZ Braid™, the central component of our technological platform in all Implanet products: JAZZ™ Band, JAZZ™ Lock, JAZZ™ Claw, JAZZ™ Frame and JAZZ™ Standalone”, says Nicolas Marin, Implanet’s Chief Marketing Officer.

Ludovic Lastennet, CEO of Implanet, adds: “The commercial launch of this new version of the JAZZ braid follows the granting of the 10thsuccessive 510(K) clearance by FDA, which strengthens our leadership position in this segment. Always attentive to customer feedback, we are continuing to develop and market new products at a quarterly pace, thus continuing to strictly adhere to our roadmap. This new braid heralds impending upgrades to our technological platform focused on simplifying surgical procedures and facilitating the use of JAZZ in new surgical indications.”

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.

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

The Case Against – and for – Arthroscopic Knee Surgery

By Michael O. Schroeder, Staff Writer | June 22, 2017

The prospect of resolving nagging knee pain – or discomfort that’s come on fairly sudden – drives many patients to go under the knife, specifically to have an arthroscopic knee procedure done.

During the procedure, an orthopedic surgeon inserts a tiny camera – or arthroscope – through a small incision to view the inside of the knee. The doctor then attempts to surgically address the knee pain, such as making repairs to a torn meniscus – a C-shaped disc that cushions the knee – or realigning a misaligned patella or kneecap.

“There are some limited circumstances where it’s helpful,” says Dr. Reed Siemieniuk, an internist in Toronto and a doctorate student in health research methodology at McMaster University in Hamilton, Ontario. That includes young patients who have sports injuries, or tears in the ligaments of the knee, he says, and patients who have bleeding in the knee – to try to figure out where the bleeding is coming from and address that. The surgery could also benefit individuals of any age who’ve suffered a traumatic injury to the knee, such as a meniscus tear. An example of a good candidate for arthroscopic knee surgery would bea 30-year-old who twists his knee getting up from a seated position or while playing tennis, says Dr. Joseph Bosco, a professor and vice chair of the department of orthopedic surgery at NYU Langone Medical Center.

But a meta-analysis led by Siemieniuk of research on arthroscopic knee surgery strongly recommended against knee scoping “in nearly all patients with degenerative knee disease.” The clinical practice guideline was published in the BMJ in May. The analysis evaluated arthroscopic knee surgery for degenerative knee disease, which is often synonymous with knee arthritis. “It is knee pain or locking that occurs with use or overuse. The most common risk factor is being overweight or obese,” Siemieniuk explains. “We use the term degenerative knee disease rather than arthritis because some surgeons restrict the diagnosis of arthritis to those diagnosed by X-ray or MRI when in reality, many people have degenerative knee disease with normal X-rays and MRIs.” Meniscus tears are also a common finding in those with arthritis, or degenerative knee disease, and are not associated with knee symptoms, but are often used as a reason to operate, he adds.

Spine Surgery Is No ‘Magic Cure’

From professional golfer Tiger Woods’ multiple spine surgeries dating back to 2014, to Golden State Warriors head coach Steve Kerr’s failed back surgery in 2015 and its resulting complications, a very bright public spotlight has been placed on the efficacy of spine surgery. The understandable question on many an “average Joe’s” mind is: If it didn’t work for them, how can it possibly work for me? The answer to that question requires a much deeper exploration of the intent of spine surgery and the many considerations required of both the surgeon performing it and the patient undergoing it.

First, it’s important to point out that success stories abound for many people who have experienced enough spine trouble to lead them down the path of exploring surgery to fix it. Some credit their new pain-free life to their spine surgeon after a successful surgery because they believe they’ve been given a second chance at a fully functional life. These quality of life transformations are awe-inspiring, and as a spine surgeon, these stories of success are my greatest victories and deepest sources of inspiration.

Though I have made spine surgery my career and have utmost confidence that a successful operation can change someone’s life for the better, the fact remains that sometimes spine surgery does fail. Now, you may be thinking, why would a spine surgeon tell me this? The answer is simple: honesty. The truth is, there are many reasons why a spine surgery may or may not work, and it’s my job to ensure that every one of my patients and the public, who may be considering surgery, thoroughly understands the benefits and risks before deciding on any type of spine treatment.

 

READ THE REST HERE

Nasdaq Stockholm Welcomes Bonesupport to the Main Market

Stockholm, June 21, 2017 — Nasdaq (Nasdaq: NDAQ) announced that Bonesupport Holding AB (short name: BONEX), a small cap company within the health care sector, has started trading of its shares on the main market of Nasdaq Stockholm. Bonesupport is the 63rd company to list at Nasdaq’s Nordic markets* in 2017.

Bonesupport is a Swedish commercial stage orthobiologics company aiming to improve the lives of patients suffering from bone disorders. The company develops and commercializes injectable bioceramic bone graft substitutes to treat bone voids, based on its novel, proprietary Cerament technology platform. Bonesupport is headquartered at the Ideon Science Park in Lund, Sweden, with additional sales offices in Germany and the US. For more information, please visit www.bonesupport.com.

“We are pleased to have completed our IPO on the Nasdaq Stockholm main market and that our shares have started trading today,” said Richard Davies, CEO of Bonesupport. “Our listing is a key step in supporting Bonesupport’s growth strategy. Our IPO has provided us with the funds to drive our sales in both the US and Europe, to generate additional clinical data to enhance the competitive positioning of our products, to complete the Fortify study, which is key to gaining US approval for Cerament G, and to invest in our pipeline. This strategy will allow us to deliver our 2020 financial targets and to generate significant value for shareholders.”

“We welcome Bonesupport to the Nasdaq Stockholm main market,” said Adam Kostyál, SVP and Head of European listings at Nasdaq. “We continue to see a strong inflow of health care sector companies leveraging the public markets as a platform for future growth, and Bonesupport will make an exciting addition to that list.”

*Main markets and Nasdaq First North at Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm.
About Nasdaq

Nasdaq (Nasdaq: NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 89 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to 3,800 total listings with a market value of $11 trillion. To learn more, visit: http://business.nasdaq.com

Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland, Nasdaq Riga, Nasdaq Stockholm, Nasdaq Tallinn, Nasdaq Vilnius, Nasdaq Clearing and Nasdaq Broker Services are respectively brand names for the regulated markets of Nasdaq Copenhagen A/S, Nasdaq Helsinki Ltd., Nasdaq Iceland hf., Nasdaq Riga, AS, Nasdaq Stockholm AB, Nasdaq Tallinn AS, AB Nasdaq Vilnius, Nasdaq Clearing AB and Nasdaq Broker Services AB. Nasdaq Nordic represents the common offering by Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm. Nasdaq Baltic represents the common offering by Nasdaq Tallinn, Nasdaq Riga and Nasdaq Vilnius.

Cautionary Note Regarding Forward-Looking Statements

The matters described herein contain forward-looking statements that are made under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about Nasdaq and its products and offerings. We caution that these statements are not guarantees of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements involve a number of risks, uncertainties or other factors beyond Nasdaq’s control. These factors include, but are not limited to factors detailed in Nasdaq’s annual report on Form 10-K, and periodic reports filed with the U.S. Securities and Exchange Commission. We undertake no obligation to release any revisions to any forward-looking statements.

Media Relations Contact:
Erik Granström
+46 73 449 78 07
erik.granstrom@nasdaq.com

Zyga Receives New Patent Allowances for SImmetry® Sacroiliac Joint Fusion System

MINNETONKA, Minn., June 21, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced the issuance of a new US Patent representing continued advancement of the SImmetry Sacroiliac Joint Fusion System.

US patent number 9,662,124 relates to the design of the company’s proprietary SImmetry Decorticator®. This surgical instrument enables surgeons to prepare the sacroiliac (SI) joint for fusion by creating bleeding bone and space for autologous bone graft. This is accomplished through a minimally-invasive, lateral approach that avoids disruption of supporting ligaments around the SI joint.

Earlier this year the Company released results of a 19-patient, prospective, multi-center study of Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication. At 24 months post-op, 94 percent of patients had evidence of bridging bone across the SI joint, with 83 percent categorized as solid fusion. Of patients with solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion. In addition to fusion, the study demonstrated a 73 percent reduction in average pain. Based on these data, the Company is currently sponsoring the EVoluSIon Study, a prospective, 40-site, 250-patient trial to evaluate long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

“Zyga remains committed to advancing true fusion technology and the field of SI joint fusion,” said Jim Bullock, president and CEO of Zyga. “Zyga now has seven issued patents related to preparing the SI joint to establish a true biologic fusion.  The expansion of our intellectual property and ongoing support of clinical trials such as the EVoluSIon study further demonstrate Zyga’s leadership in innovation for minimally-invasive spine surgery.”

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic LBP derives from the sacroiliac jointii.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, a non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.

i Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ii Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

SOURCE Zyga Technology, Inc.

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