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NuVasive to Get SafePassage and Boost Services Strategy

NuVasive to Get SafePassage and Boost Services Strategy

NuVasive said it will acquire SafePassage, a provider of intraoperative neurophysiological monitoring (IONM) services, for an undisclosed amount. The acquisition will solidify NuVasive's position as the largest provider of outsourced IONM services, the San Diego-based spine company said.

The deal comes at the end of a challenging year for NuVasive. The company has experienced significant management turnover this year, and the company is currently engaged in an ugly legal battle with competitor Alphatec. NuVasive says former exec Patrick Miles schemed for more than a year to disparage the company before jumping ship, but Alphatec defended Miles and called the lawsuit a "frivolous PR stunt."

The abrupt departure of former chief operating officer Jason Hannon and chief financial officer Quentin Blackford prompted a 42-page report from short-seller GlassHouse Research. The report suggested that the turnover was no coincidence and accused NuVasive of using an "acquire-at-all-cost" strategy to achieve its $1 billion revenue goal for the year.

“Based on our own calculations, we believe that the core business is suffering greatly at [NuVasive] and is being masked by recent acquisitions,” the authors noted.

Whether that is the case or not, NuVasive's proposed acquisition of SafePassage is expected to strengthen the company's intraoperative neuromonitoring business line, which was formed in July 2016 when NuVasive acquired Biotronic NeuroNetwork and combined its service offerings with that of the company's subsidiary, Impulse Monitoring. Following the acquisition of SafePassage, NuVasive is expected to support more than 100,000 IONM cases a year in the United States.

The company said there is limited overlap between existing healthcare accounts, making the acquisition complementary to its current geographical footprint.

"The acquisition of SafePassage advances the NuVasive services strategy and expands our ability to transform how spine procedures are approached, measured and valued from a clinical and economic perspective," said Skip Kiil, executive vice president of global commercial of NuVasive. "As the only spine company in the world with dedicated neuromonitoring services operating at this elevated scale, and now with increased case coverage, we are uniquely positioned to deliver greater value across our procedurally-integrated portfolio."

NuVasive expects the transaction to be accretive to the company's non-GAAP earnings per share in 2018 and beyond. The deal is slated to close in January.

Here's the Secret Behind Boston Scientific's New DBS Device

Boston Scientific Corp. Here's the Secret Behind Boston Scientific's New DBS Device
 FDA approved Boston Scientific's Vercise deep brain stimulation system to treat symptoms of Parkinson’s disease.

Unlike traditional deep brain stimulation (DBS) systems that are built from pacemaker technology, Boston Scientific's Vercise DBS is modeled from cochlear implant technology and the precise stimulation of auditory nerves it uses to replicate hearing. The device is now FDA approved for the treatment of Parkinson's disease symptoms, the company announced this week.

"The cochlear implant technology, when you think about it, is really designed and engineered to precisely stimulate the auditory nerves to produce a sense of hearing,"

Maulik Nanavaty, a senior vice president at Boston Scientific and president of the company's neuromodulation business, told MD+DI. "It's not just listening to a certain tone, but if you're listening to music you can hear everything, not just a single tone."

Nanavaty said that traditional DBS technology stemmed from pacemaker technology. That means it had a single source of power and was designed to stimulate the muscle, he said.  So even though the lead gets placed in the target area where physicians are trying to stimulate, the stimulation is still coming from a single source of power.

By building the Vercise DBS on cochlear implant technology, the device is able to precisely stimulate the area that needs stimulation in order to optimize the therapy, Nanavaty said.

"The reason that's so important is that the real estate of your brain is worse than Manhattan, so you want to be able to go and just stimulate the area you want to stimulate and minimize the side effects because there's a whole bunch of brain structures all around you," he said.  

This increases the therapeutic window, Nanavaty said, which improves the longevity of the therapy.

The Vercise System, which first launched in Europe in 2012, has the smallest implantable pulse generator on the market, and Nanvaty said it is very easy to recharge through the skin. It also has a battery life of more than 15 years. 

The Vercise System leads have eight contacts with a long total span of 15.5mm, tight spacing between each contact of .5mm, and multi-lumen construction, the company noted. These system features are designed to work together to address common challenges in DBS therapy such as fluctuations in symptoms and the progressive nature of the condition by offering more adaptable delivery of stimulation.

"Our system stands apart from the field in its approach, and is changing the traditional definition of how we can leverage technology to treat patients with Parkinson's disease," Nanavaty said.

FDA approved the device based on the INTREPID study, which was the first multicenter, prospective, double-blind, randomized sham-controlled study of DBS for Parkinson's disease in the United States. The study evaluated the safety and effectiveness of the Vercise System in 292 patients at 23 sites. Boston Scientific said the study met its primary endpoint of mean change in waking hours with good symptoms control (in 160 patients). Data from the study is expected to be released next year.

The company said it also submitted safety data from the European multicenter, prospective, single-arm VANTAGE study to support the FDA filing. In that study, 40 patients treated with the Vercise DBS demonstrated a 63% improvement in motor function at 52 weeks from baseline as measured by the Unified Parkinson's Disease Rating Scale III, Nanavaty said. The VANTAGE study also demonstrated improvements in quality of life and medicine use.

Nanavaty said the company is studying the use of the platform in the treatment for stroke rehab patients and Alzheimer's patients. Cleveland Clinic used the Vercise System to perform the first DBS surgery for stroke recovery nearly a year ago (Dec. 19, 2016) as part of an ongoing trial assessing the procedure's potential to improve movement in patients recovering from a stroke.

“If this research succeeds, it is a new hope for patients that have suffered a stroke and have remained paralyzed after a stroke. It is an opportunity to allow our patients to rehabilitate and gain function and therefore gain independence,” said Andre Machado, MD, PhD, chairman of Cleveland Clinic’s Neurological Institute. “Our knowledge to date shows that deep brain stimulation can help the brain reorganize, can help the brain adapt, beyond what physical therapy alone can do. The goal of our study is to boost rehabilitation outcomes beyond what physical therapy alone could achieve.”

Helping Patients Be Compliant with Medical Device Use

Helping Patients Be Compliant with Medical Device Use
Image courtesy of Bioventus LLC

“What is the most costly medical device?” Kevin Tanis asked the audience at BIOMEDevice San Jose 2017 last week as he began his presentation, “Case Study: Driving Patient Compliance.”

His answer: “A device prescribed but never used.”

Tanis serves as director of product development and engineering for Bioventus LLC, which markets a bone-healing device for home use. Patients are prescribed the device after experiencing some sort of healing delay; 20 minutes a day for up to 6 months can help speed up healing. (In some markets, the company will reimburse patients for their co-pay if they don’t heal, but they must be at least 80% compliant and have their physician confirm the lack of healing.) Compliance with the device was already quite high, he said, but the company sought to drive it higher.

Tanis said his team considered several questions as the company devised its plans for redesign: “How do we design improved compliance? How do you get people to feel the need to be compliant? How do we know if the patient is using the device?” he shared.

Each time the device was used, the session was logged on the device and the completed treatment count was shown to the user when the device was turned on, but not all users understood what the device’s flashing counter meant, Tanis explained. (It was detailed in the manual, but he said that over 60% of the manuals for devices returned to Bioventus were never opened.) His team considered whether such use data would be better understood if transmitted to an app, the patient, or a doctor or nurse. To do so, “we’d have to consider adding a cellular chip and establishing a portal,” he said. “So what would the ROI and cost be if we sell thousands of devices a year?” The company also considered having the data transmitted to them, but that, too, could cost a lot.

Another consideration was to ask doctors and nurses to download the compliance data during patient visits or to drop data somehow into patients’ electronic charts, but office staff didn’t want to be responsible for that, Tanis said. “Physicians said, ‘don’t give me anything that will give me or my staff more work to do.’ " This included any software updates, he added.

Bioventus’s eventual solution was to present compliance data to patients in a way that they could understand. The team developed a “Compliance Calendar” that would calculate compliance rates and display results on the device’s screen. For international markets, it developed a universal calendar that primarily used numbers and symbols.

The impact of the design changes was significant. “We analyzed 12,984 data files, which included data from the earlier device and from the next generation,” he recounted. “Patient compliance with the next-gen device with the calendar was 83.8%, compared with 74.2% for the previous version. Giving patients feedback did lead to an increase in patient compliance.

“It proves the point that we can drive compliance by adding features,” he continued. “Compliance does fall off toward the end of treatment, but in using the compliance feature, it never falls below 75%, compared with 51%.”

Tanis told the audience that the company is still exploring what further steps can be taken. “Possibly an app, but medical device app usage is known to drop off very quickly,” he said.

How Much Should Device Designers Really Know about Micro-Coaxial or Twin-Axial Cables?

How Much Should Device Designers Really Know about Micro-Coaxial or Twin-Axial Cables?
Image courtesy of Hitachi Cable America

Educating designers is a crucial element in specifying the right cable for the right job. As cables become smaller, the complexity of manufacturing these micro-cable designs increases, as do the challenges of obtaining reliable products to meet or exceed the performance criteria. At a certain gauge (approximately 44 AWG {0.002-in. [0.06 mm] outer diameter} and smaller), the list of capable vendors quickly dwindles. Having a better understanding of micro-cable manufacturing considerations will allow designers to make better decisions when it comes to specifying such a product.

Medical devices such as ultrasound catheters, catheter vision systems, and ablation technologies often require extremely small electrical cables for delivering the signals and power consistently throughout a procedure. For some disposable applications, the wire or cable costs must be low enough to meet the cost targets. This is a significant challenge.

As minimally invasive surgical procedures grow in market demand, medical OEMs are looking to reduce both cost and risk. Their focus is shifting toward disposable devices and vendor consolidation to drive down product costs while creating a more-robust supply chain. Even though there are fewer suppliers, the suppliers that are being awarded the business are getting larger opportunity shares in order to incentivize them for further cost reductions and supply-chain improvements. This consolidation is happening and has already happened in many organizations.

Disposable applications support reducing the risk of patient infections and post-procedural complications. Many of the new techniques drastically reduce the time required for a procedure and the length of in-patient hospital stays. This is critical to reduce risk and cost for hospitals and insurance providers, which do not want to pay for costly or what might be deemed an unnecessary or non-reimbursable procedure. With medical costs still on the rise and many hospital procedures not receiving adequate coverage, the burden of lowering costs has been pushed to the device OEMs, where every aspect is scrutinized.

Discussing upfront the design objectives for a cable is critical. Having such “design for cost” conversations sooner rather than later can mean all the difference to a product’s success. Many designers believe that as a cable or wire grows smaller, the cost should naturally drop because less material is used, but this is simply not the case. With very small gauge sizes (46, 48, and 50 AWG), delicate equipment for line processing and conductor/insulating materials play a very significant role in the cost of the product.

For example, conventional non-alloy products simply do not work well at the fine-wire sizes. They are too weak and exhibit inadequate tensile and elongation properties for even the best processing equipment. Also, these machines are very expensive. They typically reside in highly specialized work cells with significant overhead cost and associated training requirements. This is especially true of fine-wire braiders. These braiders cannot run at the same rate (speed) as conventional larger-wire braiders, so this not only extends cable lead time, but it also increases product cost. Every single level of manufacturing requires time and precision, so the smaller the wire, the longer the process usually takes.

Designers want all the benefits of a smaller size, but they need to understand that size is the attribute they are paying for the most. The smaller the cables get, the more challenging they become. This is why volume and product/program longevity are important aspects for driving down design cost. Many things can be planned for upfront if the long-term goals are known. Contractual agreements can be made. New equipment can be ordered to expand capacity. New equipment can be designed to improve product throughput. Materials can be bulk procured at a lower cost. Products can be manufactured in lower-cost regions of the world. These are all aspects that come into play with volume. Sadly, lower-volume cables will simply not be as cost effective as their higher-volume counterparts. This is partly why R&D is so expensive. Low-volume development is timely and not always cost efficient. This is also why it is so crucial to know which technology to apply and when, in order to achieve the design intent, while lowering cost and reducing manufacturing time.

To better understand this, it is important to first review the most common cable types and what they’re good for:

  1. Hookup wire. An insulated, unshielded wire typically used for single-ended signaling. Enamel-coated magnet wire is one such example.
  2. Micro-coax. A single insulated central wire with a co-axial shield and outer jacket, typically used for single-ended signaling. Coaxes are good for video and applications requiring moderate- to high-frequency/high-data rates.
  3. Unshielded twisted pairs (UTP) and shielded twisted pairs (STP). UTP is essentially two insulated wires twisted helically around each other for the length of the cable. STP applies a shield over a twisted pair, and the shield can be either isolated or non-isolated from its neighboring pairs. Twisted pairs are generally used for differential signal applications.
  4. Twinaxials. These are very similar in construction to a shielded twisted pair except there is no twisting of the wires. Twinax designs have a shield and, in some ways, perform like two coaxials in parallel. With the wire lengths matched, this improves the impedance consistency for the differential signal.
  5. Quads. These are essentially two twisted pairs in a bundle. Opposing wires act similar to twisted pairs. Quads can be shielded or unshielded, depending upon the need.

Of these five styles, designers must mix and match between the needs of the system and the assembly factors. The construction and material options are not endless, but there is still a considerable amount of detail that should be taken into account. Below is how the cable types generally break down in terms of cost (from least expensive to most expensive):

In theory, a twisted pair will generally be cheaper than a micro-coax or micro-twinax design, but designs requiring a smaller size might want to lean toward coax for performance, durability, signal isolation, and ease of termination. A really good coax is pretty hard to beat.

Other factors such as wire gauge size (as it relates to material consumption, i.e., larger the wire, the more raw-material cost), jacket material selection, shield design (tape/foil, spiral, braid, or a combination of all), product durability, flex life, electrical performance, noise susceptibility, product termination, and overall diameter size are all critical concerns. Finding the right balance between performance and cost means tradeoffs are needed. Having a small cable that reliably performs in critical environments, such as an operating room, should always trump cost. Too many people set their sights on lower costs, and they lose focus on the real objective of improving patient care. Plus, if a product outperforms the competition, it’s very likely that as a result it will also outsell the competition.

Designers should work with their cable suppliers. They should be flexible in the design and be upfront about the most-critical concerns so that tradeoffs can be properly understood. They should share as many details as possible, such as system frequency; power and grounding needs; device length; termination criteria; product intended use and potential misuse situations; crosstalk concerns; size constraints; and bundling requirements, if more than one cable and type is required. Believe it or not, even bundling can have an impact on cost and manufacturing complexity.

Michael Levesque, a sales engineer in Hitachi’s Performance Cable Systems & Materials Division, recently explained how a simple color change can positively impact cable cost in a recent MD&DI article: “A Simple Cable Modification to Reduce Cost.” This article highlights the subtle impact that manufacturing steps have on an overall cable cost. He demonstrates how adding additional colors to the cable results in the non-obvious effect of lowering the overall assembly cost.

Understanding the manufacturing process is always valuable. Customers should visit their suppliers whenever possible. Sometimes seeing the equipment in operation makes all the difference in understanding how a product is made and the impact that a design change might have.

Hitachi Metals and Hitachi Cable America specialize in the field of very small cables and cable bundles. Hitachi Cable America and Hitachi Metals can provide design suggestions to help those designers feel more comfortable about choosing the right cable design to achieve their end goals. Feel free contact Hitachi via its Website or visit the company at MD&M West in Anaheim February 6th - 8th at Booth #4069.

5 Signs That Medtech is Still 'Deal'icious

Stryker's pending acquisition of Entellus Medical, valued at about $662 million, and Edwards Lifesciences' $250 million purchase of Harpoon Medical (including milestone payments) grabbed the most attention last week, but there were several smaller deals that were also noteworthy. LivaNova reported plans to acquire ImThera Medical for up to $225 million, most of which is tied to milestones, and Medtronic bought Crospon, in a deal that has been pegged at about $45 million, although the terms were not officially disclosed. Philips acquired both VitalHealth and Forcare, though the terms were undisclosed. The one thing all of these deals seem to have in common is that they all have the potential to strengthen an existing portfolio that the acquiring companies have not spent as much time on in recent years. These transactions also suggest that companies are shopping more for the small to mid-sized tuck-in acquisitions and less for the huge blockbuster deals that the industry had grown accustomed to.

In the past week alone, there have been at least six acquisitions reported across the medical device and diagnostics industry, ranging in value from about $45 million to $662 million.

Medtronic Scoops Up an Irish Endoscopy Diagnostics Player

Crospon Medtronic Scoops Up an Irish Endoscopy Diagnostics Player
In May, FDA cleared the Endoflip system with Flip topography module, an imaging software that displays real-time esophageal contractility patterns on a touch-screen to help gastroenterologists investigate for conditions such as achalasia, GEJ outflow obstruction, and other disorders of peristalsis during endoscopy.

Medtronic has added two endoscopic devices to its portfolio through an acquisition that could be worth up to $45 million, according to various media reports.

The new acquisition, Galway, Ireland-based Crospon, provides Medtronic with a functional luminal imaging probe called the Endoflip. The device consists of a balloon catheter that is inserted into the area being measured and injected with a conductive solution to enable electrodes in the balloon to record voltage. The Endoflip builds up a picture of the geometry of the esophagus, pylorus, and anal sphincters using high-resolution impedance planimetry, according to Crospon.

Crospon CEO John O’Dea broke the news last week through a LinkedIn post. Crospon is "delighted" to have Endoflip become part of Medtronic's gastrodiagnostic platform "sitting alongside category leaders such as Manoscan, Pillcam, SmartPill, Bravo, and Digitrapper," he said.

At least four Medtronic executives also commented on O'Dea's post, offering congratulations and welcoming him to the company.

In May Crospon received FDA clearance for the Endoflip system with Flip topography module, an imaging software that displays real-time esophageal contractility patterns on a touch-screen to help gastroenterologists investigate for conditions such as achalasia, GEJ outflow obstruction, and other disorders of peristalsis during endoscopy.

The company also has a second device, the Esoflip, that is designed to work in conjunction with the Endoflip to enable doctors to measure stricture size throughout the balloon dilation process without fluoroscopy.

As of posting time, Medtronic has not officially announced the deal, but Irish business publication Flora reported that a company spokesperson confirmed the acquisition of Crospon.

State of the U.S. Market for Dental Bone Graft Substitutes and Other Biomaterials

Kjerstin Michaela/ State of the U.S. Market for Dental Bone Graft Substitutes and Other Biomaterials

The dental bone graft substitute and other biomaterials market includes dental bone graft substitutes (DBGS), dental growth factors, and dental barrier membranes. The DBGS market is relatively stable with an increasing shift towards allografts. Already representing the largest segment of total DBGS materials, the allograft market is expected to grow at a 5.8% compound annual growth rate (CAGR) by 2023.

The most innovative market in dental biomaterials is dental growth factor technology. However, these products have been slow to make strides on the market due to their relatively high price point. As such, growth within the DBGS and other biomaterials market is predominately stimulated by growth of the dental implant market in the United States.

Dental Growth Factors Continued to be limited by High Associated Costs

In 2005, FDA approved the release of BioMimetic’s GEM 21S, the first growth factor matrix approved for dental use. The product has since gained traction and received CE mark approval to enter the European market in 2012. However, in comparison to the United States, there are far less commercially distributed products in other regions such as Asia and Europe.

Dental growth factor products currently offered in the U.S. market are the GEM 21S, INFUSE, Osteocel, and Emdogain. Over the next several years, a number of additional growth factor combinations are expected to enter the tissue engineering product market. However, the total growth factor market is not expected to experience substantial growth in the United States. The high cost associated with growth factor products is the greatest limiter of market growth. As some growth factor products are cross-indicated for both dental and orthopedic purposes, major price reductions are not justified as these solutions typically generate more revenue from orthopedics. Nonetheless, smaller dose products have been growing in the market, such as the 0.15 ml Emdogain growth factor in comparison to the traditional 0.7 ml vials. As new and more affordable products are introduced into the market and as pricing pressures emerge, dental growth factor use will become more common.

Growth of the Dental Implant Market is Driving Growth of DBGS and Associated Materials

Growth in the dental implant market in the United States is also stimulating growth of the corresponding market for DBGS and other biomaterials. The dental implant market in the United States will continue to grow rapidly over the next several years. Since bone grafting is performed in preparation for nearly 60% of dental implant procedures, this growth will result in an increased demand for DBGS. Increased demand from procedures associated with dental implants will account for the bulk of DBGS sales volume growth. One of the key market drivers for dental implants is the demand for improved aesthetics, which in turn affects the DBGS market.

The consequent growth of the DBGS market will in turn push the dental barrier membrane market forward. Dental bone grafting procedures often necessitate the use of a barrier membrane to direct the growth of the new bone and gingival tissue. The demonstrated growth of dental bone grafting procedures, driven largely by the dental implant market, will lead to a corresponding long-term increase in the number of membranes used. The barrier membrane market is therefore expected to experience parallel growth, in terms of unit sales, with the dental bone graft substitute market.

Purchasing in Bulk Threatens Potential Market Growth

A common trend across the dental industry is to supplement large scale purchases with complimentary or discounted products. As periodontists and oral surgeons outnumber general practitioners in terms of dentists placing implants in the United States, and as these specialists tend to buy in bulk, this trend is expected to persist in the future. Free units of DBGS materials threaten the market by dragging down the overall market value. As bulk purchases equate to a promotion of total DBGS units being given away for free, the overall growth in the value of the DBGS market is limited.

With regards to growth factor sales, there tends to be a great deal of discounted deals to compensate for the high initial cost. In the past, most dental growth factor distributors reduced prices in an attempt to attract consumers and increase the rate of market penetration. In addition, the fragile distribution channels of Osteohealth prompted the company to endorse discounted deals on their GEM 21S sales, which is almost always sold on discount. The company provides substantial price markdowns on large-scale purchases of GEM 21S.

Long-Standing Market Leader Geistlich Expected to Continue to Lose Market Share to Emerging Competitors

In recent years, the company has lost a notable amount of market share due to the emergence of new competitors on the market which offer relatively inexpensive solutions. Nonetheless, Geistlich continued to lead the total market for dental bone graft substitutes and other biomaterials in 2016.

Its Bio-Oss bovine xenograft product line in the xenograft realm of DBGS is recognized as the gold standard within the xenograft market. While autografts and allografts are more osteoinductive than xenografts, the high quality, guaranteed supply and the proven clinical efficacy of Bio-Oss have allowed Geistlich to capture a large percentage of the bone graft substitute market. However, Geistlich’s overall market share will continue to be challenged over the next several years. ACE Surgical and BioHorizons pose future threats with their xenograft products, with BioHorizons representing a newer player to the market in 2016.

The company also benefits from a strong standing in the dental barrier membrane market, which stems from its popular collagen membrane Bio-Gide product line. This product portfolio consists of Bio-Gide Perio; an extension of the Bio-Gide product that maintains the same biological properties yet is advertised to offer ‘improved handling characteristics for periodontal procedures.


US Market Report Suite Dental Bone Graft Substitutes 2017 – MedSuite

How Google is Helping Make Sense of Your Genome

Pixabay/QIMONO How Google is Helping Make Sense of Your Genome

It’s been over a decade since the Human Genome Project, and in the years since, scientists have become quite efficient at sequencing DNA. Entire genomes can now be sequenced at incredible speeds, but sorting through nucleotides and creating hypotheses about their role remains guesswork. This week, Google released a new tool that aims to use artificial intelligence and machine learning techniques to begin to bridge that gap — helping scientists build a more accurate picture of the human genome from sequencing data.

The new tool, known as DeepVariant, was designed to help turn high-throughput sequencing readouts into a more precise picture of the full human genome. Through a process that automatically identifies small insertion and deletion mutations, along with single base pair mutations, the new tool can quickly and seamlessly create a more complete picture of a full human genome with little effort.

The process of high-throughput sequencing has been widely available since the early 2000s, but scientists initially lacked the ability to interpret the data being collected. Over the years, different technologies have begun to help researchers analyze some of these large datasets, but the complete picture has consistently remained elusive.

Researchers from Harvard’s School of Public Health, where early versions of DeepVariant have been tested, say the tool could go a long way toward helping scientists unravel some of the most difficult parts of the human genome. For years scientists have struggled with distinguishing small mutations from random errors generated during the sequencing process, specifically in repetitive portions of the genome. Scientists have theorized that many of these mutations may have direct links to various diseases or cancer.

For years researchers have attempted to analyze these readouts by using a variety of different software programs, however, these tools typically used machine approaches that relied on simple statistics to identify mutations by ruling out certain read errors. The end result was essentially a limited, error-prone snapshot of a human genome.

This is when researchers from Google’s Brain team decided to step in, developing a new tool that could focus on developing advanced AI techniques that could collect millions of high-throughput reads, and feed that data through a deep-learning system to help interpret it. In an effort to avoid the errors that other tools produced, the Google Brain team continued to adjust the model until it could interpret all the sequenced data with high accuracy — essentially through the use of deep learning techniques that could automatically train the system to perform better.

The team believes that the tool could be used to begin establishing the genetic links between various diseases and cancers. Considering that many doctors already use family history when diagnosing and treating patients, imagine a world where your entire sequenced genome could be analyzed by artificial intelligence. Doctors may be able to identify specific risk factors for each individual patient and begin treatment regimens to help prevent disease and cancer before they even begin to take shape in the body.

As the group moves forward with their research, the next step is to begin mapping these genetic variants so that doctors can begin to use that knowledge to identify life-saving therapies. Google has already begun to invest heavily in machine learning techniques and AI technologies, as both will be needed to help take genomic medicine to the next level.

Stryker Sniffs Out a Tuck-In Opportunity for ENT

Pixabay Stryker Sniffs Out a Tuck-In Opportunity for ENT

Stryker has agreed to acquire Entellus Medical, a company focused on minimally invasive treatments for various ear, nose, and throat (ENT) disease states, for about $662 million ($24 a share).

Plymouth, MN-based Entellus has a broad portfolio of ENT products, including the XprESS multi-sinus dilation system and the Latera absorbable nasal implant, which Stryker said will complement its existing ENT device portfolio.

Stryker expects the deal to be dilutive to its 2018 adjusted net earnings per diluted share by roughly $0.04 and accretive thereafter. 

The news didn't seem to move the Kalamazoo, MI-based stock [NYSE: SYK], which closed Thursday at $151.15, a 0.40% dip from its opening price. Entellus shareholders, on the other hand, seemed more enthusiastic, judging by the nearly 50% jump the stock took [NASDAQ: ENTL] to close the day at $23.99 a share.

Tuck-in acquisitions like Entellus are consistent with Stryker's M&A track record. CEO Kevin Lobo made it clear during the company's 2016 fourth-quarter earnings call in January that the company would be actively looking for acquisitions in 2017 and that it had the financial capacity and bandwidth across its divisions to do more deals.  

In September, Stryker closed its $701 million acquisition of Novadaq, a developer of fluorescence imaging technology that provides surgeons with visualization of blood flow in vessels, and related tissue perfusion in cardiac, cardiovascular, gastrointestinal, plastic, microsurgical, and reconstructive procedures.

In late October, the company announced plans to acquire Vexim, a French company that makes vertebral compression fracture solutions.

How a New Device Could Ease the Pain of Biologics

Portal Instruments How a New Device Could Ease the Pain of Biologics
Portal Instruments is developing a device designed to deliver biologic drugs through the use of a pressurized liquid instead of through standard needle-based injections.

Portal Instruments, a new medical device startup out of Cambridge, MA, announced a partnership this week with Japanese pharmaceutical giant Takeda to develop a new needle-free drug delivery device to help treat chronic conditions. The new device has the potential to treat a wide range of conditions that require drugs to be injected through a needle, specifically GI diseases like ulcerative colitis and Crohn's disease.

The partnership will combine Portal's delivery device with Takeda's investigational or approved biologic medicines. The technology is designed to deliver drugs through the use of a pressurized liquid, which has been clinically shown to be less painful compared to standard needle-based injections. The device comes with a computer-controlled system that automatically adjusts for changes in the drug’s viscosity to deliver a precise 1 ml dose of drugs in just half a second. The device can even be used by patients in their own home, providing patients with a simple solution for self-administered treatments without requiring physician assistance.

Portal will receive initial funding from Takeda, with the potential to earn additional payments of up to $100 million subject to the achievement of specified development, regulatory, and sales-based milestones. Portal also plans to utilize Takeda’s R&D team to help introduce the technology to patients and begin to grow the platform.

Stefan Koenig, global program and brand lead at Takeda Pharmaceutical, said in a press release this week that the new partnership will help support patients with chronic conditions by evolving the treatment and management of their disease without the pains of needle-based injections.

“There is a need for options to keep improving the experience for patients with life-long, chronic conditions that are managed with intravenous infusions of biologic medicines,” he said. “This partnership with Portal demonstrates Takeda’s leadership in supporting patients with GI diseases, and our commitment to evolve the management of these diseases, such as inflammatory bowel disease, by potentially offering patients the ability to administer treatment in their own home with a needle-free system.”

The technology was originally developed at MIT by Ian Hunter, a professor of thermodynamics, who was looking to design a device that could successfully deliver drugs without the use of needles. The result was a new device that could deliver virtually any biological medicine that currently requires administration through an injection.

Researchers have already begun investigational testing with Entyvio, a monoclonal antibody used on adults with moderately to severely active ulcerative colitis or Crohn’s disease. The drug is typically administered through intravenous infusion, but a current clinical trial program is currently evaluating the safety and efficacy of administering the drug using the new device.

The two companies expect the new technology to provide patients with a simple, fast, and pain-free drug delivery system in their own home, while completely eliminating the need for handling and disposing of needles.