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Articles from 2018 In August


Biodesix Makes the Case for VeriStrat Through New Study Courtesy of Biodesix

Biodesix Makes the Case for VeriStrat Through New Study

The Biodesix VeriStrat test received an extra dose of validation last week through a 1,048-patient study published in the Oncologist. The study demonstrated the prognostic value of the VeriStrat test in patients with non-small cell lung cancer (NSCLC).

VeriStrat is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC.

Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples. Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice.

Researchers used samples from the Phase 3 MARQUEE trial and found that the VeriStrat (VS) test was a significant predictor of outcomes, independent of ECOG Performance Status categories, patient EGFR (epidermal growth factor receptor) mutation status, treatment received, and other clinical variables.

In the EGFR mutation-positive subgroup, patients with a VS Good result experienced improved overall survival as compared to patients with a VS Poor result when treated with a single-agent EGFR-tyrosine kinase inhibitor (EGFR-TKI).

When the combination of two EGFR-TKI therapies was used, patients with VS Good results still outperformed those with VS Poor results, but those with VS Poor results performed better on the combination therapy than on erlotinib alone, thus indicating the need for an alternative treatment strategy, which may include novel combination therapies. In contrast, the patients with a VS Good result did not receive significant benefit from the additional agent.

“The results were not surprising to us,”  Linda Traylor, Ph.D., vice president of Clinical Development and Medical Affairs for Biodesix, told MD+DI. “[However], this is the first study to be published with such a large number of mutation positive patients.”

BioDesix picked up Integrated Diagnostics for an undisclosed sum in an attempt to build on its lung cancer detection offerings.

How a Design Tweak Triggered a CPAP-Related Product Recall

How a Design Tweak Triggered a CPAP-Related Product Recall

Sometimes even the most simple design changes can create a safety issue. That seems to be the takeaway from a Class I recall that one manufacturer of a continuous positive airway pressure (CPAP) mask is dealing with.

Compass Health is recalling the replacement cushion seals for the Probasics Brand Zzz-Mask SG Full Face CPAP Mask due to a design change made to the cushion seal replacement part and accompanying elbow replacement part that causes the seal to be incompatible with the mask. The company initiated the recall in May and sent an urgent notice to customers on June 19, and FDA announced on Friday that the recall has been placed in the Class I category, which is considered to be the most serious type of medical device recall.

FDA said no patient complaints or injuries have been reported, but the use of the new cushion with the previous design of the mask could result in an air leak that interrupts therapy. The use of the affected mask seal may cause serious adverse health consequences, including increased risk of bronchitis or pneumonia, apnea, high blood pressure, heart attack, or even death.

The replacement seals included in the recall were manufactured after May 1, 2015, and distributed between May 4, 2015, and October 10, 2017.  The agency said the recall includes 742 products that were distributed nationwide.

  The Probasics Brand Zzz-Mask SG Full Face CPAP Mask is designed for patients requiring CPAP for the treatment of obstructive sleep apnea in the home, hospital, or another clinical setting. CPAP machines use mild air pressure to keep airways open during sleep. The air is delivered through a mask that fits over the nose and mouth. The mask contains an elbow adapter which allows the user to connect the mask to the CPAP machine. The mask cushion is used for both comfort and to provide a seal between the face and the mask.

Any consumer using an incompatible cushion/elbow combination are being instructed to discontinue use of the mask and contact their dealer for a replacement kit. Dealers do not need to return the affected product to Compass Health, according to FDA's recall notice, but all affected products in stock should be disposed of.

See FDA's recall notice for further instructions regarding the product in question.

Susan Tull, an IP attorney from Finnegan
Susan Tull, an IP attorney from Finnegan

A Few Things SaMD Developers Should Know

In today’s digital and connected society, clinicians and patients alike are beginning to expect the same capabilities in medicine. There’s tremendous opportunity for healthcare innovation and transformation through software—but as a developer, do you know how to proceed in terms of regulations and intellectual property protection?

FDA’s guidance for Software as a Medical Device (SaMD) provides regulatory answers. When issuing its guidance, FDA cited its adoption of the regulatory framework developed by the International Medical Device Regulators Forum (IMDRF). This voluntary global group of medical device regulators has defined SaMD as the "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Susan Tull, an IP attorney from Finnegan, says these recently promulgated guidelines have aided SaMD developers in understanding whether they need to seek FDA approval and what is required to obtain that approval. To address the challenges related to getting and protecting patents for SaMD technologies, Tull answered a few questions from MD+DI.

Is there anything unique or particularly challenging given the role software will play in healthcare, a highly regulated market with privacy, reimbursement, and cost concerns?

Tull: SaMD developers will need to be cognizant of privacy regulations and HIPPA requirements when collecting and distributing patient information. Patient information is strictly regulated, and this may be a new concern for developers who are not used to handling this type of information. Insurance reimbursements will also be a new issue for companies that do not typically occupy the medical field and should be a consideration when weighing potential profits versus costs and associated risks.

Today, are SaMD developers typically employees of a medical device company, or are they external vendors working for multiple medical device companies? What are the benefits and challenges with each model, for the developer and for the company?

Tull: Many traditional medical devices already rely on embedded software to operate, so those companies would already have a model in place to develop source code. We are seeing a mix of SaMD developers. Some are employees of traditional medical device companies, others are external vendors developing the software for those companies, and still others are companies that have compatible technology looking to move into the medical device space. An example of the latter are companies that make fitness trackers and heart rate monitors that are looking to apply their sensing technology to medical diagnoses.

The benefits of these different models are largely the same in terms of the final product, namely a SaMD platform. Each company considering this space and the different models would need to consider the cost of employing one or more software developers versus hiring an external vendor to perform the work, how many SaMD platforms or products they are hoping to launch and over what period of time, and how likely is it that the SaMD will require frequent updates. An important consideration for any company using external software developers is to be sure that any employment or consulting contract addresses the question of IP ownership and assignment. You would not want to make significant investments into a SaMD product only to realize after the fact that the developer could sell the same product to other companies.

I imagine there is a lot of testing, trial and error, and ongoing development in SaMD. When should intellectual property (IP) protection be pursued?

Tull: While it is good to consider IP protection throughout the entire development process, the question becomes much more urgent once the product is near final or when FDA approval is sought. Companies will want to ensure that they protect their final commercial product, but early prototypes or concepts should also be considered for IP protection as they may prove valuable in the future.

It is important for companies that are required to submit a 510k application to FDA to seek IP, and in particular patent, protection before FDA clears the product and publishes the approval summary. Once the FDA summary is published, the 510k application is considered public and may be accessed through FOIA requests, including by competitors. A company will only have one year from the publication of that approval to file a patent application before the 510k application can be used to prevent them from obtaining a patent.

When should IP protection not be pursued?

Tull: Before deciding whether or not to pursue IP protection, a company should consider the different types of protection available to it. A company can receive a utility patent on the idea underlying the SaMD, a design patent for the layout or appearance of an app used with the SaMD, trademark or trade dress protection for the brand and name, and copyright protection for the written code.

If those specific categories do not apply, for example, if the SaMD is not unique to the developer or company, then IP protection may not be available and thus should not be pursued.

The length of time it takes to obtain IP protection and the associated costs are also factors in deciding whether to obtain IP. For example, it often takes over two years to obtain a utility patent. Software can evolve very rapidly and by the time a patent is issued, it may no longer cover the commercialized product. In that instance, a company may decide not to pursue IP protection.

In addition, a patent expires 20 years after the date the patent application is first filed. Once a patent expires, anyone is free to use the technology described in the patent. If a company can keep core technologies or concepts confidential for longer than that 20-year period, they may wish to keep the invention as a trade secret. In that instance, not seeking IP protection may make better sense for the company in question.

What challenges are there related to the branding of SaMDs?

Tull: Many SaMDs use phone apps as part of the product. The layout and appearance of those apps may be covered by design patents or trade dress protections owned by a third party. Before pursuing a particular brand or app appearance, a company should make sure that they are not infringing another’s design patent, trade dress, or trade mark.

What other IP considerations should SaMD developers be aware of?

Tull: SaMD developers should also keep in mind issues presented by open source licensing and defensive publications. Open source software is publicly accessible and can be modified and shared by others. Open source software may be used for underlying technology that is not critical to the SaMD, like the operating system or application programming interface. This would include software used to operate a phone’s camera, for example, if the SaMD relied on photos taken by the user. A developer that plans on using open source software should review any accompanying licenses when selecting the open source software. Companies that hire external developers should ask the developers about open source software as well.

If a company has determined that they do not wish to pursue patent protection, they should consider a defensive publication of their technology and ideas. A defensive publication can be used to prevent another company from obtaining a patent on the same technology.
 

Avinger Seeks Nod for Small Vessel Version of Pantheris Pixabay

Avinger Seeks Nod for Small Vessel Version of Pantheris

Avinger is pursuing a number of different indications to effectively position its Pantheris lumivascular atherectomy system to treat peripheral arterial disease (PAD) in a variety of different patients.

The Redwood City, CA-based company’s latest news on this front is its submission of a 510 (k) application to FDA for the Pantheris Small Vessel (SV) Lumivascular atherectomy system.

“We also plan on filing for CE mark for clearance of the small vessel device in Europe soon after our U.S. submission,” Jeff Soinski, Avinger CEO, said according to a Seeking Alpha Transcript.

The company said it was hopeful the device could be cleared in the U.S. sometime in 2019.

With a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal regions of the vasculature.

The firm has been busy pursuing a slew of indications for the Pantheris platform, which has been available in the US market since 2016. In May, Avinger received FDA clearance for its next generation Pantheris image-guided atherectomy device. The technology has been successful thus far the company said.

“Based upon the positive case experience and impressive clinical outcomes in initial sites in the U.S. and in Germany beginning earlier this year, we made the decision to launch the next-generation Pantheris more broadly to our installed base in June,” Soinski said according to a Seeking Alpha Transcript. “Since that time, we've discontinued all sales of our previous version of Pantheris in both the U.S. and in Europe and are now selling the next-generation device in two versions, the A400, which has a standard nosecone and the A400X with an extended nosecone with the ability to capture up to 70% more plaque in a single insertion.”

Avinger executives spoke with MD+DI in March and said the company is working to secure an indication to treat in-stent restenosis (ISR). In October of 2017, patient enrollment began to evaluate the safety and effectiveness of Pantheris when treating ISR. The study is expected to enroll up to 140 patients in 20 sites. The company said ISR represents about 20% of PAD procedures in the U.S.

The company would have a six-month-follow up for the patients, which should be complete in 2019. The firm would submit to FDA sometime after.

The Line Between Drugs and Devices Continues to Blur

The Line Between Drugs and Devices Continues to Blur

Otsuka America Pharmaceutical has signed a collaboration agreement with Magellan Health designed to facilitate access to the first drug-device combination product approved by FDA to track drug ingestion. The agreement creates an opportunity for doctors and adult patients to gather experience in a real-world setting with the Abilify Mycite System, Princeton, NJ-based Otsuka said on Thursday.

The Abilify Mycite System is the perfect example of how the line between pharma and medtech continues to blur, which isn't necessarily a bad thing. The product is comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor developed by Redwood City, CA-based Proteus Digital Health. But getting the product to the U.S. market hasn't been easy. 

Both the Abilify drug and Proteus's sensor were approved and cleared by FDA separately years ago, but the companies needed the agency's blessing to sell a version of Abilify that incorporates the sensor directly into the pill. As MD+DI reported at the time, the companies submitted a new drug application (NDA) to FDA in September 2015 seeking approval for the drug-device combination product, but the agency sent Otsuka and Proteus a complete response letter in April 2016 asking for more information about the combo system.

Otsuka and Proteus's luck changed late last year, however, when FDA approved the Abilify Mycite drug-device combination product comprised of Otsuka’s oral aripiprazole (an antipsychotic drug) tablets embedded with an Ingestible Event Marker (IEM) sensor. In addition to the pill and embedded IEM, the system also includes a wearable sensor, developed by Proteus, a smartphone app to display information for the patient, and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. The IEM sensor that is embedded into the pill is the size of a grain of sand (1 mm) and made up of ingredients found in food.

Otsuka said the Abilify Mycite System provides an opportunity for a connected care approach to treatment and tracks if the pill has been taken. This can be especially important for complex patient populations such as those with serious mental illnesses like schizophrenia, bipolar disorder, depression, and Tourette syndrome, which are the conditions Abilify is most prescribed for.

“We are confident that being able to track drug ingestion in patients with serious mental illness will provide compelling insights for patients and their healthcare provider teams. We are eager for patients, doctors and the healthcare community to experience the Abilify Mycite System in a real-world setting,” said Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business, Otsuka America. “This collaboration agreement is an important milestone in our initial rollout of the Abilify Mycite System to market. We look forward to collaborating with additional payer groups to continue learning as we move toward a data-driven treatment approach.”

The initial rollout of the system is purposeful and patients in select regional provider networks contracted through Magellan Health will receive the opportunity to opt into the program, Otsuka explained. By focusing on fewer individuals using the drug-device combination system at first, Otsuka and Magellan Health will be better able to understand how it fits within the daily lives of those with serious mental illness and their caregivers, how doctors will integrate it into their daily practice, and how patients may benefit from more information about their care. As a result, Otsuka will be able to consider ways to improve the system to enhance the experience and better serve prospective patients, their caregivers, and physicians in the future, the company said.

“Our collaboration with Otsuka is a natural progression for Magellan Health in providing next-generation precision medicine that can empower individuals with serious mental illness,” said Magellan Healthcare CEO Sam Srivastava. “The opportunity for new insights to drive personalized care for the individual will also allow us to enhance our digital tools and care management model that we offer for our members. This collaboration aligns with our purpose of leading humanity to healthy, vibrant lives through a joint commitment to improving patient outcomes for complex populations.”

David Nash, MD, dean of the Jefferson College of Populationo Health at Thomas Jefferson University in Philadelphia, PA and chair of the Digital Medicine National Steering Board sees the collaboration between Otsuka and Magellan as a win for the space.

“This is an exciting time, from a population health perspective, as we gather insights into factors that influence adherence to treatment and consider the related clinical and economic implications,” Nash said.

Stryker to Pick up K2M for $1.4B Pixabay

Stryker to Pick up K2M for $1.4B

Stryker has thrown in its bid to acquire one of the 25 most attractive medtech companies on the M&A radar. The Kalamazoo, MI-based company said it was acquiring K2M, a specialist in complex spine and minimally invasive, in a transaction $1.4 billion.

Specifics of the deal show that Stryker has agreed to acquire all of the issued and outstanding shares of common stock of K2M in an all cash transaction for $27.50 per share.

The purchase price represents a 27% premium over K2M’s average closing price during the 90 trading days ended Aug. 29, 2018. The deal is slated to close in late 4Q18.

The move would help boost Stryker’s spinal division.

“This acquisition underscores our commitment to the spinal market, which is the largest segment of Orthopedics with significant unmet needs,” Kevin Lobo, chairman and CEO of Stryker, said in a release. “We believe K2M will significantly enhance our presence with surgeons, patients and employees in both the spine and related neurotechnology markets.”

Leesburg, VA-based K2M went public in 2014. The company is known for its Balance ACS platform of products, services, and research designed to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes.

K2M's Serengeti minimally invasive retractor system garnered a Medical Design Excellence Award in 2010 and was included later that year on MD+DI's list of 50 Companies to Watch.

"K2M's main focus is complex spine, which we believe is an attractive segment since the procedures are typically performed by high-volume surgeons and generate significant revenue per case," Mike Matson, an analyst with Needham & Co,  wrote in a research note. "K2M faces only two key competitors in complex spine (Johnson & Johnson and Medtronic) and its innovative products including its MESA 2 system  have enabled it to gain significant share in this segment. And we note that K2M's CEO, Eric Major, is expected to stay at Stryker to become president of its spine business."

Stryker noted in its 1Q18 earnings call that it was going to focus on M&A this year.

"I think you should assume going forward that M&A is going to continue to be a priority in terms of our use of cash because we're committed to driving faster organic sales growth at the high end of medtech," Katherine Owen, Stryker's vice president of strategy and investor relations said during the company's first-quarter earnings call in April.

Stryker had been in the M&A conversation this past June. The company was rumored to be interested in acquiring Boston Scientific. However, Stryker shot down such rumors disclosing on a regulatory form that it was not in discussions with Boston Scientific Corporation regarding a potential acquisition."

FDA Addresses Severe Lack of Pediatric Devices Pixabay

FDA Addresses Severe Lack of Pediatric Devices

To address the scarcity of medical devices that are designed specifically for the pediatric population, FDA convened a public meeting and workshop August 13–14, 2018 to delve into the financial, regulatory, and design constraints associated with this challenging endeavor.[1] Speakers at the workshop included FDA regulators, sponsors, clinicians, and members of the American Academy of Pediatrics. The prevailing message from the workshop was that while there are many barriers to the development of pediatric-specific devices, FDA and community in attendance is committed to developing innovative pathways and solutions to promote bringing pediatric devices to market.

General Takeaways

      1. Adult medical devices are often used off-label for pediatric patients

Both sponsors and FDA recognize that the use of adult devices for children is not ideal, but because of the many barriers to pediatric device development, off-label use is necessary and will continue until sufficient pediatric specific devices are available. Development of pediatric medical devices lags behind adult devices by five to ten years.

      2. The development of pediatric medical devices is difficult for sponsors

Attendees to the workshop had meaningful discussion on how to expand the medical device market for pediatrics. However, presenters outlined the multitude of challenges faced by sponsors including the very small pediatric medical device market, evolving pediatric patient’s physiological development, and the great difficulty of running clinical trials in a pediatric population.

      3. The pediatric medical device community is interested in incentives to develop pediatric medical devices

Dr. Lynne Yao, Director, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, FDA, presented on current incentives and legislation in place for the development of pediatric-specific drugs which could be translated into an incentive system for development of pediatric-specific medical devices. Throughout the workshop, sponsor speakers emphasized the need for incentives to drive the development of pediatric-specific medical devices.

      4. FDA provides data leveraging options to extrapolate adult data or use quality real-world data

The Pediatric Extrapolation for Devices (PEDs) team within CDRH works specifically to evaluate submissions for pediatric devices and highlighted that outside of randomized controlled trials for new devices, CDRH encourages extrapolation of known adult data to determine the safety and effectiveness of a device for pediatric use. FDA also highlighted their interest in evaluation of real-world data (e.g., clinical data from off-label use and data published in literature) to determine safety and effectiveness of new devices.

What about Human Factors?

Of particular concern is that the concept of human factors or device usability was never discussed at the workshop. It seems that the field of pediatric medical devices is still navigating ways to even develop new devices, so evaluation of device usability may not yet be a high priority. However, there are many opportunities to optimize designs and better serve pediatric patients with the application of human factors during the design process. It also is apparent that some sponsors are already focusing on usability for pediatric patients. For example, in August 2018, Vectura released study findings from a phase 2 trial evaluating the ability of young children and toddlers with asthma to use its nebulized inhaler.  Vectura’s study enrolled 40 children, 1 to 4 years old, to examine their ability to use Vectura’s inhaler to deliver a fixed-dose formulation of the corticosteroid budesonide. According to the company, the study showed 90% of children age 2 and up were able to effectively use the mouthpiece which demonstrated tight control of breathing patterns with no loss of medication. Because of these findings, Vectura is also developing a facemask for children under 2. Usability studies are an important part to ensuring safety and effectiveness for devices which require primary use by children. Although it was not discussed at the workshop, it is important for sponsors to take the necessary steps to integrate human factors evaluations into the design process for new devices to help develop the safest products for end users (and not only rely on practices such as extrapolation of adult use data).

Important Human Factors Considerations for Pediatric Devices

       1. The development of pediatric devices can benefit from human factors considerations

Because FDA’s workshop did not discuss usability, it seems sponsors may be missing the opportunity to integrate human factors into the design process in order to optimize use related safety and effectiveness. There is extensive scientific findings which highlight the developmental process of children and outline cognitive and motor stages of development that would be paramount to consider for this special and important user population.

       2. It is vital that sponsors consider human factors for pediatric devices as they make plans for development of safe and effective devices

As demonstrated by the Vectura study, sponsors are aware that usability by children can be different than adult users. Sponsors should consider the necessity of conducting human factors evaluations with pediatric users early during the development process, such as when identifying a regulatory pathway and device development plan. It is also important to consider the specialized skills required to perform usability studies with children, as this user population presents different challenges to their adult counterparts.

      3. Extrapolation of adult usability data may not sufficiently demonstrate use related safety and efficacy of devices for children

While the PEDS team within the CDRH highlighted their acceptance of extrapolated clinical adult data as a potential substitute to randomized controlled trial data, it must be highlighted that children are different from adults. Caution must be applied in assuming that adult usability data will be representative or applicable to children. Per Applying Human Factors and Usability Engineering to Medical Devices that was published by CDRH, FDA on February 3, 2016, “If intended users include a pediatric population, the testing should include a group of representative pediatric users; when a device is intended to be used by both pediatric and adult users, FDA views these as distinct populations.” In the same guidance, FDA highlights the following characteristics that impact the user’s ability to operate the medical device: physical size, strength, dexterity, coordination, sensory abilities, cognitive abilities, literacy, level of education and motivation to learn a new device. This is a non-exhaustive list of the numerous characteristics that likely will be different for pediatric and adult users, which will directly impact usability.

For sponsors committed to creating safe and effective medical devices for pediatric use, they should prioritize working with human factors professionals who have specific experience in medical devices and in navigating FDA regulatory pathways. Tools such as early expert/heuristic reviews in the design process can significantly improve device usability for children, and human factors formative and validation studies will help optimize the design and prepare evidence for sponsors and FDA to know pediatric devices are safe and effective for end users.

Agilis is a  human factors partner for the global medical market. The firm helps new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. 

[1] https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596777.htm

 
 
Investors' Faith in Outset Overwhelming with Whopping $132M round Courtesy of Outset Medical

Investors' Faith in Outset Overwhelming with Whopping $132M round

When Leslie Trigg took the helm of Outset Medical in 2013, she helped lead a $60 million series B round. The San Jose-based company was also working to get the Tablo Hemodialysis system, a device that simplifies dialysis procedures, on the market.

But oh, how things have changed.

Outset Medical has seen Tablo gain a nod from the FDA in 2015 and has even seen a surge in investor and consumer interest in the device. Earlier this week, Outset Medical executives revealed the company closed on a $132 million a series D equity round.

The round was backed by some heavy hitters and led by new investor Mubadala Investment Company, active in numerous sectors and more than 30 countries around the world. Existing investors Baxter Ventures, the venture capital arm of Baxter International, Fidelity Management and Research Company, Partner Fund Management LP, Perceptive Advisors, funds advised by T. Rowe Price Associates Inc., and Warburg Pincus also participated in the equity round.

“The funds are going to be used to expand our manufacturing capacity and to accelerate commercial expansion,” Trigg, told MD+DI. “Having [just] come out of a [limited release], we’re ready now for full-scale commercial release. The series D was closed to finance that effort.”

Tablo was designed to transform what Outset executives say is a large but stagnant, dialysis landscape. With real-time water purification and dialysis fluid production integrated in a single, compact system, Tablo functions like a dialysis clinic on wheels. Requiring just an electrical outlet and tap water to operate, Tablo frees providers from having to rely on expensive clinic infrastructure, enabling on-demand, cost-effective dialysis in a range of different use environments.

Trigg said that people are in disbelief when they first hear about Tablo and that there has been a great deal of response about the device.

“The response has been - is this for real,” Trigg said. “Can you really miniaturize an entire water treatment room into a 15-inch box?”

She noted that once they see the device in action all doubts are put to rest. Plans call for Outset Medical to seek additional indications for Tablo.

“Probably the next milestone behind [our full commercial launch of Tablo] would be the completion of the clinical trial for home-use and then a submission to FDA for an expanded use of Tablo that would potentially include the use of the [device] in the home,” Trigg said.