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June 19, 2017

Stryker (SYK) to Acquire Novadaq (NVDQ)

Stryker announced that it has reached a definitive agreement to acquire Novadaq $11.75 (USD) per share, or $701 (USD) million with a net purchase price of $654 (USD) million, reflecting net cash of approximately $47 (USD) million. The transaction will be carried out by way of a court approved plan of arrangement under the Canada Business Corporations Act and will require the approval of the holders of at least 66⅔% of the Novadaq Shares present in person or represented by proxy at a special meeting of Novadaq shareholders to be called to consider the Arrangement. The Special Meeting is expected to be held on or about August 4, 2017.



In addition to shareholder and court approvals, the Arrangement is subject to applicable regulatory approvals, including Canadian Competition Act and U.S. Hart-Scott-Rodino approvals, and the satisfaction of certain other closing conditions customary in transactions of this nature. The transaction is not subject to a financing condition. The Arrangement Agreement includes a non-solicitation covenant on the part of Novadaq, subject to a right to match provision and customary fiduciary out provisions, and provides for the payment of a termination fee of $21.0 (USD) million by Novadaq to Stryker in certain circumstances.



See more on Novadaq and Stryker on Meddevicetracker.



ResApp Completes SMARTCOUGH-C Enrollment

ResApp announced that it has completed enrollment of the Pivotal SMARTCOUGH-C study of its ResAppDx application for respiratory disease. The study, which began in December 2016, intends to evaluate the efficacy of the ResAppDx software application in diagnosis of pneumonia and other respiratory conditions, as well as support a De Novo request submission through the United Sates Food and Drug Administration. As top-line results from the study are expected by the end of July 2017, it is expected that the Company will file its De Novo request in the same time frame with a subsequent approval anticipated before the end of the year.



See more on ResAppDx on Meddevicetracker.



Alliqua Acknowledges Consumers with New Partnership

Alliqua BioMedical announced that it has entered into a partnership with Partners Capital Group to provide its potential UltraMIST customers with new equipment financing programs. Partners Capital Group is a financial services company that provides capital leasing and financing programs to customers on behalf of vendors and suppliers of equipment and software. 



Though analysts and investors alike were optimistic at Alliqua’s potential for growth in the wound healing market, they have nonetheless been left disappointed over the past several years. But Alliqua has not given up, and remains confident in its ability to grow commercially – this new partnership is a perfect example of its plan to bring more clients. To that end, given the Company’s 180-day extension from Nasdaq in April 2017 to regain compliance with the minimum bid price requirement for continued public listing in the market, watchers should be expecting some impactful events from this Company in the near future as the experienced leadership seeks to keep the Company afloat.



See more on Alliqua BioMedical on Meddevicetracker.




June 20, 2017

ConforMIS Obtains 510(k) Clearance

Following two regulatory filings, ConforMIS announced that it has obtained United States Food and Drug Administration (FDA) 510(k) clearance for the Company’s iTotal Hip replacement system. The Company originally filed for approval with the FDA in 2015, but in the course of its review of that application, the FDA raised a number of questions, and ConforMIS was not able to address all of those questions within the allowed review timeline. Therefore, after consultation with the FDA, ConforMIS elected to withdraw the application and resubmit the filing in September 2016.



As a Company that has been floundering since going public in 2015, ConforMIS and its investors should enjoy a short celebration now that the Company can step into a territory other than knee repair. However, this product alone is not likely to save the Company trading around $20 (USD) below its all-time high in 2015, and just cents above its 52-week low. Though some analysts are optimistic at the Company’s room for growth, watchers should be hesitant given the fierce competition within the Company’s respective marketplace, as it is dominated by the like of Merit Medical, Stryker Corporation and Zimmer Biomet.



See more on ConforMIS and the iTotal Hip on Meddevicetracker.



K2M Introduces Expandable Stabilization System

K2M announced has officially launched the latest addition to its interbody portfolio, the SAHARA-AL Expandable Stabilization System, a product the Company touts to be the only lordotic expandable interbody device with integrated screw fixation on the market. The SAHARA AL Expandable Stabilization System, which was granted 510(k) clearance in 2015, represents a technological advancement over static interbody options, allowing for in-situ lordotic adjustment to match a patient's sagittal profile through one fusion device. SAHARA AL is a zero-profile device with multi-screw fixation, designed to provide stability to the anterior column, while featuring a comprehensive range of lordotic adjustments of up to 26 degrees. It is indicated as a standalone device for lordotic angles of 15 degrees or less. SAHARA AL is manufactured from commercially pure grade II titanium, titanium alloy, and cobalt chrome.



As a Company that has been on a steady rise, it is no wonder that K2M has shown bullish growth in the stock market over the past 12 months with its 47% growth since last June. In the same time frame the Company has garnered eight 510(k) clearances through the United States Food and Drug Administration (FDA), with several more – including subsequent launches – to be expected in the near future. With the addition of the new SAHARA-AL, it is safe to expect more growth by the Company as they continue to compete with the likes of NuVasive, Zimmer Biomet, and Johnson & Johnson.  



See more on K2M and the SAHARA AL on Meddevicetracker.




June 21, 2017

Meditech Receives 510(k) Clearance for Spinal Implants

Meditech Spine announced that it has received clearance from the United States Food and Drug Administration (FDA) to market the Company’s latest Talos Lumbar (HA) Peek IBF lumbar fusion implants for use in skeletally mature patients suffering from degenerative disc disease (DDD). The intervertebral body device can be used with autograft and/or allograft of cancellous and/or corticocancellous bone graft in DDD patients with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Furthermore, the product will be marketed with Peek-Optima HA enhanced material provided by Invibio Biomaterial Solutions, a United Kingdom based polymer solutions firm. The Company noted that the decision to incorporate the Peek-Optima material was supported by nearly two years of clinical evidence and positive feedback from surgeons.



This clearance represents Meditech’s fourth FDA clearance in the past two years. And with six new lumbar interbody fusion devices to be released in the next year, this privately held company looks determined to take on its more established competitors in a crowded market.



See more on Meditech and the Talos Lumbar (HA) Peek IBF implants on Meddevicetracker.




June 22, 2017

 K2M Doubles Down On This Week’s Bullish Sentiment

Just days after launching SAHARA-AL Expandable Stabilization System, K2M further augmented its portfolio and bullish market sentiment with the announcement of 510(k) United States Food and Drug Administration (FDA) approval of its MOJAVE PL 3D Expandable Interbody System. The product, which features Lamellar 3D Titanium Technology, is a fusion device design to allow for independent control of the anterior and posterior height in the lumbar spine – something that K2M claims is not offered by any other product on the market to date. 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. 



 As was mentioned previously, the Company seems to be gaining significant market share with the steady release of new products. In fact, its market cap recently hit the $1 Billion (USD) mark, further revealing to its competitors, large and small, that it plans to continue shaking up the orthopedics marketplace with the unceasing development of novel products intended for use in ever-growing populations of patients.



See more on K2M and the MOJAVE PL 3D Expandable Interbody System on Meddevicetracker.



Exactech Continues Japanese Expansion


Exactech announced the first clinical use of several of its recently approved shoulder, knee and hip replacement systems in Japan this quarter. The Company noted that 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. Lastly, the first Equinoxe Reverse Shoulder system was implanted June 5 at Sano Memorial Hospital.



The clinical use of these products in Japan further bolster the company’s global footprint in orthopedics, as it seeks to remain a big player in a marketplace dominated by Zimmer Biomet, Stryker Corporation, and Johnson & Johnson. With a market cap well above $350 million (USD), stable leadership, and a growing need for orthopedic implants as the general population of people 65 years and older is expected to almost double by 2050, Exactech seems optimistic to maintain itself as a key player in cartilage and joint repair.



See more on Exactech and its products on Meddevicetracker.



Thermo Fisher Obtains Approval for Companion Diagnostic

Thermo Fisher announced that the United States Food and Drug Administration has granted premarket approval (PMA) for the Company’s first next-generation sequencing (NGS)-based test, the Oncomine Dx Target Test.  The test, which was developed in collaboration with Pfizer and Novartis, simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies (Tafinlar + Mekinist, XALKORI, and IRESSA) for non-small cell lung cancer (NSCLC). As timing in cancer treatment is critical, this product will be a significant benefit to NSCLC patients as its simultaneous screening capability will allow physicians to match patients with the best cancer therapy in a matter of days rather than several weeks.



The Company notes that this first iteration of the test, as it expects to expand the panel’s screening capabilities in the future. In fact, Thermo Fisher has already held discussions with several anonymous pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond just lung cancer.



See more on the Oncomine Dx Target Test on Meddevicetracker.



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