Biotech

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Cellectar Biosciences Inc CLRB Stock News

Cellectar Biosciences Inc (NASDAQ: CLRB) was the topic of key coverage by Ladenburg Thalmann recently. The firm reiterates its buy rating with a strong price target on the stock. Here’s what the firm had to offer…





Ladenburg Thalmann Reiterates Buy On CLRB

As mentioned above, Cellectar Biosciences was recently the center of a research report, created by Ladenburg Thalmann, that proved to be overwhelmingly positive. The firm announced that it has reiterated its buy rating on the stock thanks to encouraging CLR131 Cohort 4 data, the new collaboration with Onconova, and the progress of existing collaborations along with an enhanced cash position. As a result, the firm maintained their Buy rating with a price target of $3.10.




CLRB Reports Encouraging Cohort 4 Data

As mentioned above, one of the key factors in the reiteration of the Buy rating at Ladenburg Thalmann was the fact that CLRB recently reported encouraging Cohort 4 data surrounding the CLR 131 Phase 1 dose-escalation study in relapsed or refractory multiple myeloma. 3 patients who were heavily pretreated with high tumor burden were enrolled into Cohort 4. One of the patients saw an 82% reduction in serum free light chain, a partial response. The other 2 patients also achieved stable disease, including 1 patient with a 44% reduction in M protein. These data proved to be overwhelmingly positive.

Recent Collaboration News

Another bit of information that led to the reiteration of the Buy rating as well as the strong price target was the fact that CLRB recently signed a collaboration agreement with Onconova. The company also extended its existing collaboration with Pierre Fabre. Through these diverse collaborations, CLRB aims to determine PLE’s ability as a versatile delivery carrier to enable more targeted and enriched delivery of diverse types of drug payloads into cancer cells. These collaborations are likely to generate promising results that will propel Cellectar further toward the top!

To read the full analysis, click here!

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on CLRB. In particular, we’re interested in following the ongoing story surrounding CLR131 and ongoing collaborations. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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DarioHealth Corp DRIO Stock News

DarioHealth Corp (NASDAQ: DRIO) is having an incredibly strong day in the market today, and for good reason. The company announced that it has received the CE mark surrounding one of its products. Of course, this led to excitement among investors, sending the stock toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:09), DRIO is trading at $2.63 per share after a gain of $0.82 per share or 45.30% thus far today.





DRIO Announces Receipt Of The CE Mark

As mentioned above, DarioHealth is having an incredibly strong day in the market today after announcing that it has received the CE Mark. The mark was received surrounding the company’s Lightning®-enabled version of the DarioTM Blood Glucose Monitoring System. This is incredible news as it helps to ensure that consumers, starting off in the UK market, will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the iPhone 8.




This is a key breakthrough in the UK market. After all, there are as many as 4 million people in the UK that have diabetes. Now, many of these consumers will have the ability to use the Dario diabetes device with their smartphones; a device that continues to shine in the UK as it has been named the “First Choice” by several Clinical Commisioning Groups for people with Type 1 diabetes. In a statement Frez Raphael, Chairman and CEO at DRIO, had the following to offer:

We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieving the CE Mark. We are proud that our organization worked with agility to ensure connectivity to the latest Apple devices. This significant milestone will allow us to open to a whole new market segment and reengage with former-Dario users who now have the newest Apple devices.

The actual Lighting-enabled prototype has been ready for a long time, and the CE Mark is just the beginning. We will continue to support our users around the world and, to that end, have begun the formal process with regulatory agencies in the U.S., Canada, and Australia.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on DRIO. In particular, we’re interested in following the ongoing efforts to further commercialize the company’s blood glucose monitoring system in the UK as well as achieve regulatory approval in the United States, Canada, and Australia. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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MannKind Corporation MNKD Stock News

MannKind Corporation (NASDAQ: MNKD) is having a relatively rough start to the trading session this morning as investors seem to be looking to sales reports, which are proving to be somewhat concerning. However, many argue that this is not a concern and that sales will soon pick up. As is normally the case, our partners at Trade Ideas were the first to alert us to the declines. Currently (10:35), MNKD is trading at $4.38 per share after a loss of $0.37 per share (7.77%) thus far today.





MNKD Releases Sales Figures For The Week Ending On October 6th

Q4 has gotten off to an interesting start for MannKind and its investors. During the first week of the quarter, the FDA approved a label change, which many believe will lead to gains in Afrezza sales. Ultimately, this prompted massive gains in the value of the stock. However, the company recently released its most recent sales report. Unfortunately, sales didn’t prove to be what investors wanted to see.

In the week ending on October 6th, MNKD announced that Afrezza prescription sales were just over 400. That proved to be a dip from the previous week. While some will blame the dip on the Columbus Day holiday, this was not included in these figures.




Clearing Up A Misconception

One of the big concerns that seems to be popping up on message boards surrounding MNKD is the recent label change. You see, when the FDA approved the label change for Afrezza, investors expected that this would lead to gains in prescription sales. So, with a dip in sales, investors are starting to become concerned that the label change isn’t doing what they thought it would do. Well, allow me to clear up a bit of a misconception here.

It’s important to remember that the prescription sales releases are somewhat delayed. This is important in this particular case because the new labels that had been approved by the FDA were freshly minted the same week that the sales figures were released for. So, the changes would have absolutely no effect on sales during the week ending October 6th. Essentially, the sales figures are based on the same notions that previous sales figures would have been based on.

Thinking About Time

Another key factor that we have to consider here is time. While Afrezza label changes will likely lead to improved sales relatively soon, this isn’t going to happen overnight. MannKind still has to make physicians aware of these label changes. This is going to take some time. Now, I’m not saying that we won’t see slight improvements in sales in the short term, but I am saying that the true value of the label change will take some time to be realized.

Added Ammunition

Another factor that can be considered here is finances. Recently, MNKD raised some serious funding; over $60 million was raised. That’s a massive amount of money, and MannKind now has the ability to expand the marketing efforts surrounding Afrezza with this money. Will they do so? While they haven’t released any plans as of yet, it would be foolish for the company not to use this funding to improve the marketing surrounding the Afrezza offering.

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The Bottom Line

The bottom line here is that MNKD has a tremendous opportunity. The company was recently the center of an approved label change surrounding Afrezza, and that alone has the ability to lift sales. This, in combination with increased funding that will likely lead to an improved marketing position, puts MNKD in a prime position for long run growth!

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STRATA Skin Sciences Inc SSKN Stock News

STRATA Skin Sciences Inc (NASDAQ: SSKN) is having an overwhelmingly strong time in the market early on this morning, and for good reason. The company announced an agreement late in the trading day yesterday that led to excitement among investors who are sending the stock toward the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:44), SSKN is trading at $2.08 per share after a gain of $0.33 per share or 18.57% thus far today.





SSKN Gains On Agreement

As mentioned above, STRATA Skin Sciences is having a strong start to the trading session this morning after the company announced that it has signed an agreement with MedResults Network, or simply MRN. This is a key agreement as MRN is a Group Purchasing Organization with more than 3,000 customers. Their customers range from dermatology offices to plastic surgery practices, facial plastic practices, MediSpas and more.




In particular, MRN focuses on the aesthetic market, creating agreements with more than 50 vendors with only one vendor per product category. This is great news for SSKN as it will be the only vendor in its category and will now have access to various customers it didn’t have before. The agreement, including special offer pricing to MRN members will lead to a launch to the membership base as early as this week. In a statement, Frank McCaney, President and CEO at SSKN, had the following to offer:

We are pleased to announce this relationship, which we believe has major benefits to STRATA. MRN has a loyal and long-term subscriber base and a reputation for providing value to its members. MRN provides additional value to its members by offering educational seminars and value to its vendors by active promotion of the products on agreement with them.

Furthermore, the products that STRATA introduced earlier this year in the Aesthetic space are outstanding, technology-advantaged products but lacked broad awareness. We believe that the reach and credibility of MRN will greatly benefit our sales efforts.”

The above statement was followed up by Jeff Routledge, President of MRN. Here’s what he had to say with regard to the partnership with SSKN:

We are excited about the opportunity to assist STRATA in marketing their products to our membership. STRATA’s Aesthetic products, Nordlys and STRATAPEN, are excellent products that are in growing sectors of the Aesthetic market. MRN’s mission is to offer our members best-in-class products from world class companies through pricing that can only be achieved by leveraging the buying power of our 3,000 member practices and medical spas.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to follow the SSKN story. In particular, we’re interested in following the relationship the company is building with MRN and excited to see the results via sales revenue. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Protalix BioTherapeutics, Inc. PLX Stock News

Protalix BioTherapeutics, Inc. (NYSEMKT: PLX) is having an overwhelmingly strong start to the trading session in the pre-market this morning, and for good reason. The company announced that it has entered into a license and collaboration agreement, leading to excitement among investors and sending the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:20), PLX is trading at $0.899 per share after a gain of $0.25 per share or 37.46% thus far today.





PLX Gains On License And Collaboration Agreement

As mentioned above, Protalix BioTherapeutics is having an incredibly strong start to the day in the pre-market hours after the company announced that it has entered into ta license and collaboration agreement. The agreement was signed with Chiesi Farmaceutici S.p.A., also known as Chiesi. The agreement surrounds PRX-102 (pegunigalsidase alfa), a chemically modified version of the recombinant protein alpha-Galactosidase-A. The treatment is currently being evaluated in Phase III clinical trials as a treatment of Fabry disease. So far, PRX-102 has demonstrated a significantly enhanced circulatory half-life and higher enzyme activity in the target organs that are generally affected by Fabry disease when compared to currently available versions of the molecule. PLX has also released data showing that the treatment is safe and effective through a completed Phase I/II clinical trial.

According to the agreement, PLX has licensed PRX-102 to Chiesi for all markets outside of the United States. In exchange, the company will receive an upfront payment of $25 million from Chiesi as well as additional payments of up to $25 million in development costs, which will be capped at $10 million per year. Protalix also has the opportunity to earn an additional $320 million under the agreement based on regulatory and commercial milestones. Finally, under the terms of the agreement, PLX will receive royalties on net sales ranging from 15% to 35%. In a statement, Moshe Manor, President and CEO at PLX, had the following to offer:




“We are pleased to partner with Chiesi, an international privately-held company with more than 80 years of experience and a strong focus on the development and commercialization of innovative medicines with commercial presence in virtually all markets outside of the United States… The $50 million commitment made by Chiesi before any of our ongoing phase III clinical trial results read-out is not only a significant non-dilutive cash infusion for us, it also represents Chiesi’s commitment to the Fabry market in general and our PRX-102 program in particular. With this transaction, we have secured significant and important funding while maintaining full rights to PRX-102 in the U.S. market.”

The above statement was followed up by Ugo Di Francesco, CEO at Chiesi. Here’s what he had to say about the agreement with PLX:

With revenues of approximately $1.8 billion, the Chiesi Group is among the top 50 pharmaceutical companies in the world. By combining the respective strengths of Chiesi and Protalix to advance PRX-102, we look forward to bringing a novel, differentiated therapeutic option to patients suffering from Fabry disease who have a true need for an alternative treatment with an improved safety and efficacy profile… PRX-102 complements our existing product portfolio in rare diseases and underscores our commitment to bringing novel therapeutics to patients across the globe.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on PLX. In particular, we’re interested in following the story surrounding PRX-102 as the treatment has proven to be safe and effective in the Phase I/II trials. We’re excited to learn the results of the Phase III clinical trials and watch as this much needed treatment is brought to the market. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!

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Aytu Bioscience Inc AYTU Stock News

Aytu Bioscience Inc (OTCMKTS: AYTU) is likely to have a strong day in the market today, and for good reason. The company announced early this morning that it has received good news from the NASDAQ Capital Market. Here’s what we saw from the announcement:





AYTU To Uplist To The NASDAQ

As mentioned above, Aytu Bioscience is likely to have an incredible day in the market today after the company announced that it has received positive news from the NASDAQ Capital Market. The company, focused on global commercialization of novel products surrounding urology announced that shares of its common stock have been approved for listing on the NASDAQ. As a result, trading on the NASDAQ will commence on Friday, October 20th, 2017 under the symbol AYTU. In a statement, Josh Disbrow, CEO At AYTU, had the following to offer:




The Company’s listing on the NASDAQ Capital Market is a major milestone for Aytu, and I’m pleased with the progress we have made in the two years since our formation. In a short period of time we’ve successfully built a portfolio of novel, urology-centric products and have scaled a fully-integrated specialty commercial organization. To augment our operational progress, we believe that listing on NASDAQ will help the Company further diversify our shareholder base and provide better liquidity and exposure for the Company as we continue on our growth trajectory.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on AYTU. In particular, we’re interested in following the ongoing work surrounding Natesto, the Japanese commercial launch of Fiera, and the rest of the company’s robust product offering. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Neothetics Inc NEOT Stock News

Neothetics Inc (NASDAQ: NEOT) is having an incredibly strong day in the market today, and for good reason. The company announced merger news that’s leading to excitement among investors and sending the stock screaming toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:03), NEOT is trading at $1.02 per share after a gain of $0.50 per share or 97.00% thus far today.





NEOT Gains On Merger News

As mentioned above, Neothetics is having an overwhelmingly strong day in the market today. The gains are here after the company announced early this morning that it has entered into a definitive agreement with Evofem Biosciences to merge the two companies. As a result, Evofem Biosciences will become a wholly owned subsidiary of NEOT through an all stock transaction. The goal of the merger is to transform Neothetics into a leading women’s health company that develops and commercializes novel products. Once the merger is closed, NEOT will undergo a name change, changing its name to Evofem Biosciences, Inc. Also, the new company will be led under the leadership of Saundra Pelletier, the current CEO at Evofem Biosciences.




Following the completion of the merger, the new joint company will receive a rather hefty investment. Invesco Asset Management Ltd, an affiliate of Evofem Biosciences announced that it has entered into a securities purchase agreement to acquire an additional $20 million of common stock in the combined company upon the completion of the merger. In a statement, Martha Demski, a member of the Neothotics Strategic Transaction Committee and Board of Directors, had the following to offer:

Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Evofem Biosciences provides the best opportunity to maximize value for Neothetics shareholders… We believe the strength of the leadership team, coupled with the completion of its pregnancy prevention trial, will enable Amphora® to reach significant value inflection points in the near term.”

The above statement was followed up by Saundra Pelletier, CEO at Evofem Biosciences and soon to be the CEO of the joint company NEOT and Evofem will create. Here’s what she had to say:

This merger and concurrent financing provides continued funding for Evofem Biosciences’ ongoing Phase III study of Amphora® as a vaginal contraceptive – AMPOWER. We expect to close the study database and file for FDA review in the second quarter of 2019… In addition, we have expanded our Amphora® clinical development platform with potential supplemental indications which would further strengthen its position as a cornerstone therapy in hormone-free birth control and as a preventative option for certain sexually transmitted infections.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on NEOT and we are excited to follow the merger and resulting benefits. Of course, we believe that the merger is a positive move for NEOT and its shareholders as Amphora brings quite a bit of value to the table. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Cellectar Biosciences Inc CLRB Stock News

Cellectar Biosciences Inc (NASDAQ: CLRB) is seeing slight gains this morning after the company announced that it has been awarded yet another patent. Of course, this led to excitement among investors, causing gains in the value of the stock. Currently (9:38), CLRB is trading at $1.72 per share after a gain of $0.01 per share or 0.51% thus far today.





CLRB Gains On Patent News

As mentioned above, Cellectar Biosciences is having a relatively strong day in the market today after the company announced that it has been awarded a new patent. The patent comes from the Japanese Patent Office, covering both composition of matter and method of use for CLR 131 and CLR 125. Both of these are phospohlipid drug conjugatesTM designed by CLRB. The compounds are composed of radio isotopes conjugated to the company’s proprietary PDC delivery platform. CLR 131 is the lead compound and is currently the center of a Phase 1 trial for multiple myeloma and a Phase 2 trial for multiple blood cancers. CLR 125 was part of the National Cancer Institute-sponsored study showing potential effect against triple-negative breast cancer. In a statement, Jim Caruso, President and CEO at CLRB, had the following to offer:




The issuance of this Japanese patent enhances our growing intellectual property portfolio in this strategically important market and underscores the novelty of our delivery platform and the potential of these compounds. Certain cancers such as head and neck and gastric are more prevalent in Asia and represent high unmet medical need both within and outside the region… The increased market protection provided by this patent combined with the ongoing NCI supported research in head and neck cancer and the early clinical benefits seen to date with CLR 131, affords us the opportunity to initiate a more global development program.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on CLRB. In particular, we’re interested in following the ongoing work surrounding both CLR 131 and CLR 125 as both of these compounds are showing incredible promise. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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EnteroMedics Inc ETRM Stock News

EnteroMedics Inc (NASDAQ: ETRM) is having a strong start to the trading session in the pre-market hours this morning as investors await a presentation that was just announced yesterday. Of course our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:09), ETRM is trading at $2.29 per share after a gain of $0.05 per share or 2.23% thus far today.





ETRM Gains Ahead Of Coming Presentations

As mentioned above, EnteroMedics is having a strong start to the trading session in the pre-market hours this morning. Yesterday, the company announced that it and its products will be the subjects of two oral presentations and one poster presentation at ObesityWeek 2017. The presentations will take place in Washington D.C. from October 29th through November 2nd. The presentations will feature vBloc® Real-World patient data, ReShape® integrated dual balloon system patient data, and Gastric VestTM System initial clinical results. For more information surrounding ObesityWeek 2017 and the involvement of ETRM in the conference, click here.




What Investors Want To See

While vBloc is an important piece of the ETRM offering, it’s not going to be the center of attention among most investors at this presentation. However, Gastric Vest and ReShape will be two big topics of discussion. As most following EnteroMedics already know, the company is working to bring Gastric Vest to market. Considering this, the clinical data that the company intends on offering at the presentation will be a key bit of information with regard to the efforts to bring the system to market. So, investors will likely be keeping a close eye on what data and other news is released surrounding the system.

On top of that, very recently, ETRM announced the acquisition of the ReShape Dual Weight Loss Balloon. This product is an FDA-approved, minimally invasive intragastric balloon designed to treat obesity patients with a BMI of between 30 and 40 with one or more related comorbid conditions. Considering that this is a recent acquisition, investors are likely excited to see the first bit of real-world data that will be released by ETRM themselves. Of course, positive data here would suggest that commercialization of the treatment will move at a decent pace, leading to strong gains in the value of the stock. In a statement with regard to the acquisition of ReShape, Dan Gladney, President, CEO and Chairman of the Board at EnteroMedics, recently had the following to offer:

We are pleased to announce this significant transaction, which adds a new minimally invasive, revenue-generating technology to the EnteroMedics portfolio… The acquisition of the ReShape Dual Weight Loss Balloon, which complements our existing products with a non-surgical weight loss solution expands our addressable market and gives us yet another touch point along the continuum of care in obesity.

EnteroMedics and ReShape Medical are two innovative companies that share a strong strategic focus on providing proprietary, patient-friendly technologies to address the global obesity epidemic… We look forward to combining the complementary expertise and capabilities of both companies for the benefit of our customers, patients, employees and stockholders.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on ETRM. In particular, we’re interested in following the story surrounding the presentation and looking forward to both the clinical data surrounding Gastric Vest and the real-world data surrounding ReShape. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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TransEnterix Inc TRXC Stock News

TransEnterix Inc (NYSEAMERICAN: TRXC) is having an overwhelmingly strong day in the market today, and for good reason. It seems as though investors are reacting to the news that was released, late Friday, surrounding the company’s SenhanceTM Surgical Robotic System. Before we get into the details, we’d like to extend a thank you to our partners at Trade Ideas for being the first to alert us to the gains. At the moment (11:25), TRXC is trading at $2.42 per share after a gain of $0.96 per share (65.75%) thus far today.





TRXC Gains On FDA News

As mentioned above, TransEnterix is having an overwhelmingly strong start to the trading session this morning after the company announced on Friday that the FDA has provided 510(k) clearance surrounding its Senhance Surgical Robotic System.

As a result of the clearance, TRXC now boasts the first new market entrant into the field of abdominal surgical robotics since the year 2000. To use the system, a surgeon directs small surgical instruments and a camera with precise movements and comfort. Senhance builds on the foundation of Laparoscopy and features the security of haptic feedback and eye-sensing camera control. This is the first time this has been seen in a robotic surgery platform.




Furthermore, the Senhance platform takes advantage of an open architecture platform. This will allow hospitals and surgeons to leverage existing technology investments in conjunction with this platform for a synchronized operating room ecosystem. The system was specially engineered to manage operative costs efficiently, helping to make robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments. In a statement, Todd M. Pope, President and CEO at TRXC, had the following to offer:

The clearance of the Senhance System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value and choices offered to patients, surgeons and hospitals… Millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize the value for the hospital. Senhance is this new choice.”

Following the statement above, Dr. Steve Eubanks, a general surgeon and Executive Director of Academic Surgery at Florida Hospital, had the following to say:

Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries…The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscpic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on TRXC. In particular, we’re interested in following the company to see the revenue generation following the 510(k) approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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Thought Leader Discussions

Gevo, Inc. GEVO Stock News

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Gevo, Inc. (NASDAQ: GEVO) Before we get into this interview, I'd like to extend a special thanks to my friend Joey who both set up the...