Year: 2021

Just five months after raising $90M, Brazil’s Nuvemshop announced today it has raised $500 million in a round co-led by Insight Partners and Tiger Global Management.

The financing values Nuvemshop – which some say is Latin America’s answer to Shopify – at $3.1 billion and brings the Sao Paulo-based startup’s total funding in the last 10 months to more than $620 million.

Sunley House Capital and VMG Partners, as well as existing backers Accel, Kaszek, Kevin Efrusy, Qualcomm Ventures LLC and ThornTree Capital also participated in the latest round.

Nuvemshop (also known as Tiendanube in Spanish speaking countries) aims to give entrepreneurs a way to build and grow online businesses. The company’s platform serves more than 90,000 merchants across Brazil, Mexico, and Argentina, ranging from direct-to-consumer (DTC) upstarts to more established brands such as PlayMobil, Billabong, Colombraro, Zaira Beauty, Osram, Lolja, Vitabe and StrappyCo. That’s up from 20,000 merchants at the start of 2020 and 80,000 at the time of its last raise in March.

Rather than selling their goods on existing marketplaces (such as Mercado Libre, the Brazilian equivalent of Amazon), many merchants and entrepreneurs are opting to start and grow their own online businesses, according to Nuvemshop co-founder and CEO Santiago Sosa.

“Most merchants have entered the internet by selling on marketplaces but we are hearing from newer generations of merchants and SMBs that they don’t want to be intermediated anymore,” he said. “They want to connect more directly with consumers and convey their own brand, image and voice.”

Virtually every KPI tripled in the company in 2020 as the world saw a massive transition to online, and Nuvemshop’s platform was home to 14 million transactions last year, according to Sosa.

Earlier this year Nuvemshop launched a beta version of its own payments solution platform for merchants that is designed to allow for “faster and more secure” purchases. It also reflects the Latin American consumers’ approach to paying for retail purchases over time. In fact, the company says that 70% of the credit card transactions on its platform happen via installments. The new product will be made broadly available to all merchants over the course of the next year.

Nuvemshop says that its logistics capabilities allow merchants to deliver directly to consumers via partnerships and integrations with what would otherwise be a highly fragmented network of carriers. The company plans to keep broadening its set of warehouse and carrier partners with the goal of driving down the click-to-delivery time in most regions — now typically 5 to 6 days — to an eventual goal of the 1- or 2-day delivery, which is now standard in the U.S.

“With 650 million consumers, Latin America is not only a huge market, but it is the fastest growing e-commerce market in the world,” said Matt Gatto, managing director at Insight Partners.

Accel Partner Ethan Choi believes the Latin American e-commerce market has the potential to be just as big as the U.S. market in the future.

“Given the rapid adoption of e-commerce, we believe Nuvemshop has the potential to be one of the most important companies in the region,
he told TechCrunch. “Looking at Shopify’s $185 billion market cap gives you a sense of what’s possible if you’re the leading eCommerce player in a big market like the U.S.”

The new capital will go toward growth in Nuvemshop’s existing markets and support expansion into new countries such as Colombia, Chile and Perú. Nuvemshop will also work to expand its capabilities to serve larger merchants by expanding its sales and customer support staff, as well as continuing to invest in resources and support for its app partners and agencies. The company additionally plans to accelerate its payment and logistics capabilities, and will use the fresh capital in part toward some acquisitions.

The company currently has more than 600 employees and offices in Brazil, Mexico and Argentina.

InfoSum, a London-based startup that provides a decentralized platform for secure data sharing between organizations, has secured a $65 million Series B funding round led by Chrysalis Investments.

The investment comes less than a year after InfoSum closed a $15.1 million Series A round co-led by Upfront Ventures and IA Ventures. Since, the data privacy startup has tripled its revenue, doubled its employee base, and secured more than fifty new customers, including AT&T, Disney, Omnicom and Merkle.

Its growth was boosted by businesses that are increasingly focused on data privacy, largely as a result of the mass shift to remote working and cloud-based collaboration necessitated by the pandemic. InfoSum’s data collaboration platform uses patented technology to connect customer records between and amongst companies, without moving or sharing data. It helps organizations to alleviate security concerns, according to the startup, and is compliant with all current privacy laws, including GDPR.

The platform was bolstered earlier this year with the launch of InfoSum Bridge, a product which it claims significantly expands the customer identity linking capabilities of its platform. It is designed to connect advertising identifiers along with its own “bunkered” data sets to better facilitate ad targeting based on first-party data.

“The technology that enables companies to safely and securely compare customer data is thankfully entering a new phase, driven by privacy-conscious consumers and companies focused on value and control. InfoSum is proud to be leading the way,” said Brian Lesser, chairman and CEO of InfoSum. “Companies are looking for solutions to help resolve the existing friction and inefficiencies around data collaboration, and InfoSum is the company to drive this growth forward.”

The company, which says it is poised for “exponential growth” in 2021 as businesses continue to embrace privacy-focused tools and software, will use the newly raised investment to accelerate hiring across every aspect of its business, expand into new regions, and further the development of its platform.

Nick Halstead, who previously founded and led big data startup DataSift, founded InfoSum (then called CognitiveLogic) in 2015 with a vision to connect the world’s data without ever sharing it. The company currently has 80 employees spread across offices in the U.S., the U.K., and Germany.

Solving the twin challenges of human and planetary health is the greatest task of our generation, and it also presents the greatest entrepreneurial opportunity in history which is why we’ve partnered with Mayfield to bring you an engineering biology track to Disrupt 2021 this September 21-23. Haven’t secured your spot yet? Grab your ticket now for $99 (or even less if you’re a student, founder, or non-profit/government employee)!

Mayfield has over 50 years of experience under its VC belt, and it got there by investing in people first, with a focus on enterprise, consumer and engineering biology companies. They have served as early investors to iconic biotech and health IT entrepreneurs throughout their 50+ year history — from Amgen and Genentech to Mammoth Biosciences — whose mission is to create a better world for this and future generations.

This track will feature insights from the founders of multi-billion-dollar companies Twist Bioscience, Gingko Bioworks and Adaptive Bio; NotCo (a rising planetary health star and Indie Bio company) and Mammoth Biosciences (a breakout CRISPR platform company co-founded by Nobel Prize winner Jennifer Doudna); plus Mostafa Ronaghi, the premier SPAC manager and former CTO of Illumina and more innovators working to solve the twin challenges of human and planetary health.

Do you science? Then you won’t want to miss any of the sessions below. Check the Disrupt 2021 agenda for days and times according to your time zone.

Bioplatforms for Saving the Planet: Mayfield’s Arvind Gupta joins two iconic entrepreneurs, Twist CEO Emily Leproust and Ginko Bioworks CEO Jason Kelly, to discuss their founder journeys — from inception through IPO and beyond — and how they are changing our world for the better.

Saving Lives with Precision Biology: Mayfield’s Ursheet Parikh joins Mostafa Ronaghi (former CTO, Illumina), Chad Robins (Co-founder & CEO, Adaptive Biotechnologies), Yan Zhang (CEO, Mission Bio) and Diego Rey (Co-founder & CSO, Endpoint Health) to talk about how these leaders are leveraging biology breakthroughs to save lives. 

Taking Care of the Next Generation: Mayfield’s Kamini Ramani joins these three exceptional leaders — Sandra Oh Lin (KiwiCo), Maneesh Jain (Mirvie) and Stu Landesberg (Grove Collaborative) — to talk about creating a better world now and for future generations, building movements and communities and the milestones in getting to escape velocity.

The New Human and Planetary Health Pioneers: Mayfield’s Arvind Gupta joins leaders of two breakout companies — Trevor Martin (Mammoth Biosciences) and Matias Muchnick (NotCo) — in a discussion about the founder journey and tips for scaling your business.

Rewiring the Brain to Improve the Quality of Life: Mayfield’s Ursheet Parikh joins neuroscientists, physicians and entrepreneurs — Nanea Reeves (TRIPP), Konstantinos Alataris (Nēsos) and Paul Dagum (Mindstrong Health) — in a discussion about building brain-based businesses that improve the quality of life.

TechCrunch Disrupt 2021 takes place September 21-23. If you science — heck, even if you don’t — be sure to catch the sessions in this special engineering biotech track to learn from visionary leaders determined to build a better world. Buy your Disrupt 2021 pass and join this fascinating conversation for under $99.

Some Bluetooth bugginess and questionable mic performance, I liked the NuraTrue, quite a bit. And obviously, I’m always in favor of smaller companies mixing it up with tech giants, while bringing something unique to the process. In Nura’s case, that thing is custom sound profiles that can dramatically enhance the listening experience.

The company has also been a proponent of the hardware as a service model. It’s a concept we’ve written about quite a bit that has yet to really catch fire with a broader audience. You pay some money up front and then effectively rent the product for a monthly fee. The company is extending the model to its NuraBuds product.

The fully wireless headphones shouldn’t be confused with the NuraTrue (honestly, though, the NuraBuds name is the better of the two). The devices are remarkably similar, but these are cheaper (and smaller) versions that drop some of the features in the name of keeping the cost down. They’re not unlike Google’s Pixel Buds A, in that respect.

The smaller size (which also drops the largely ornament circle design) also comes with a reduced battery, down from six hours to four on the buds (plus 10 additional hours via the case). How big a difference that will make to you, the user, really depends on how you use the buds. The other big difference is the NuraBuds can’t be used to perform the company’s signature hearing test.

Instead, users will have to use the app to import it from a different model. Essentially that means missing out on their best feature, unless you’ve already owned (or rented) another set of Nura headphones and saved that profile.

If that all sounds good, the buds run $5 a month through the Nuranow program, plus a $19 upfront “one-time setup” fee. The over ear Nuraphones are also available through the program for $10 a month (plus $49 up front), while the NuraLoop run $8 a month (plus $29).

Branch, which has built a flexible workforce payments platform, announced today it has raised $48 million in Series B funding and closed on a $500 million credit facility.

Lee Fixel’s Addition –– which has also backed the likes of Flipkart, Stripe and Coinbase – led the equity financing while the credit facility was secured in the form of purchased assets from funds managed by Neuberger Berman.

Drive Capital, Crosscut Ventures, Bonfire Ventures, Matchstick Ventures, and HR Tech Investments LLC, a subsidiary of Recruit Holdings Co., Ltd. (an affiliate of job search site Indeed) also participated in the equity funding, among other investors. With the latest investment, Minneapolis-based Branch has brought in a total of $58 million in equity funding since its 2015 inception.

The raise marks Branch’s first since 2017.

Branch CEO and founder Atif Siddiqi declined to reveal at which valuation the company’s current round was raised but did note that it saw 300% revenue growth year over year in 2020, and a 700% increase in the number of enterprises using its platform.

Branch was founded to give companies a more cost-effective, faster way to pay employees and  contractors, which in turn theoretically can maybe help them attract and retain talent and save money compared to using traditional payment methods. 

When Siddiqi first started the company, Branch was focused on a use case of helping workers pick up additional hours at companies they already worked at to grow their income. But then the team started looking for other ways to help these workers financially.

“One of our strengths was that we were connected to a lot of very disparate enterprise systems. And we were collecting a lot of really interesting employment data,” Siddiqi told TechCrunch. “With that data, we realized we could really build a better financial service experience for this consumer.”

Branch typically focuses on low to moderate income users, and sits between the company and its worker payment flows.

It started off with earned wage access and then began accelerating payments for workers. It has since expanded into use cases such as digital tip payments.

“One of the things we saw when we were working with a lot of Domino’s franchisees is that a lot of them didn’t have enough cash at the end of the day to tip out their drivers,” Siddiqi explains. Rather than be forced to go to an ATM to get cash, some turned to Branch’s Wallet offering, which gives franchise owners the ability to push tip payments in real time after a driver finishes a shift.

“Tips represent about 40% of a driver’s income on a monthly basis so that’s pretty significant,” Siddiqi said.

Branch then expanded into contractor payments, such as helping companies pay their 1099 contractors faster with a “uniform” payment experience.

“We realized we could rebuild a better financial service experience from the ground up, and that’s where you find Branch today,” Siddiqi said.

Siddiqi said the company tries to provide as many free options as possible such as not charging for instant transfers into the Branch Wallet and non-instant transfers to another financial account.

Like many other fintechs, the startup monetizes primarily off of interchange fees. It also charges a transaction fee for pushing funds instantly from the Branch Wallet to another financial account.

“Faster payments is a compelling and transformative benefit expected by today’s workforce,” Siddiqi said. “We’ve seen how it can significantly improve cash flow for both companies and workers, so we’re excited to deliver instant payments and other engaging tools to more sectors and workforces, from other workers living paycheck to paycheck to independent contractors growing their own businesses.”  

As part of the company’s efforts to grow beyond the multi-billion dollar earned wage access market, it has expanded into contractor and influencer payments with a new deal with influencer marketing platform Tagger and other on-demand delivery platforms. 

Branch also recently inked an agreement with Kelly, a global staffing firm. Other customers include Delivery Drivers, Inc. (DDI), an independent contractor management solution specializing in last-mile delivery, and HR and IT management platform Rippling.

The company is similar to another fintech, GigWage, but the biggest difference – according to Siddiqi –– is that Branch has built its own payment rails and system to push out funds instantly, and also has offerings for W-2 workforces.

Drive Capital Partner Andy Jenks believes that the company’s financial services address pay cycle gaps and cash flow challenges in a way “that can save time and costs for both workers and the companies they work for.”

“We’ve seen how impactful Branch’s acceleration of payments for employers and the W-2 workforce has been,” he wrote via email, “and look forward to their expansion into contractor payments where they can serve a range of rapidly growing industries such as last-mile delivery, logistics and influencers.”

Aurora Propulsion Technologies, a Finnish company that develops thrusters and de-orbiting modules for small satellites, will be sending its technology to space for the first time. The company has signed on with Rocket Lab to send its inaugural AuroraSat-1 cubesat into low Earth orbit aboard an Electron rocket rideshare mission in the fourth quarter of this year.

Aurora is part of a small number of startups have emerged over the past few years whose technology could help solve a tricky problem that, for most of us, can be summed up as ‘out of sight, out of mind’: space junk.

Space junk, or orbital debris, includes any human-generated object in space that’s no longer functional. While the Department of Defense keeps track of around 27,000 pieces of space junk through its Space Surveillance Network, there are estimated to be millions of pieces of debris floating around in low Earth orbit. As the costs of launch and other technology continues to decline, LEO is only poised to grow more crowded in the coming years – which could mean more useless junk floating around us in the long-term.

The launch with Rocket Lab later this year is the opportunity for the company to demonstrate its technology in-space. AuroraSat-1 will have two modules. The first module will contain 6 “resistojet” thrusters, designed to help cubesats quickly de-tumble and adjust their attitude control, or the satellite’s orientation. Aurora will also test its Plasma Brakes, which use an electrically charged microtether to generate drag for satellite de-orbiting.

AuroraSat-1 was originally scheduled to fly with in-space transportation provider Momentus on board a Space X Falcon 9 rideshare mission earlier this year, but that flight was halted after Momentus failed to receive approvals from the Federal Aviation Administration.

Regarding the switch up, Aurora CEO Roope Takala told TechCrunch that “in light of Momentus’ difficulties, we had to re-manifest the satellite onto the now published Rocket Lab flight.” Aurora announced in March it had signed on to launch a satellite with Momentus in June 2022.

Aurora Propulsion Technologies, a Finnish company that develops thrusters and de-orbiting modules for small satellites, will be sending its technology to space for the first time. The company has signed on with Rocket Lab to send its inaugural AuroraSat-1 cubesat into low Earth orbit aboard an Electron rocket rideshare mission in the fourth quarter of this year.

Aurora is part of a small number of startups have emerged over the past few years whose technology could help solve a tricky problem that, for most of us, can be summed up as ‘out of sight, out of mind’: space junk.

Space junk, or orbital debris, includes any human-generated object in space that’s no longer functional. While the Department of Defense keeps track of around 27,000 pieces of space junk through its Space Surveillance Network, there are estimated to be millions of pieces of debris floating around in low Earth orbit. As the costs of launch and other technology continues to decline, LEO is only poised to grow more crowded in the coming years – which could mean more useless junk floating around us in the long-term.

The launch with Rocket Lab later this year is the opportunity for the company to demonstrate its technology in-space. AuroraSat-1 will have two modules. The first module will contain 6 “resistojet” thrusters, designed to help cubesats quickly de-tumble and adjust their attitude control, or the satellite’s orientation. Aurora will also test its Plasma Brakes, which use an electrically charged microtether to generate drag for satellite de-orbiting.

AuroraSat-1 was originally scheduled to fly with in-space transportation provider Momentus on board a Space X Falcon 9 rideshare mission earlier this year, but that flight was halted after Momentus failed to receive approvals from the Federal Aviation Administration.

Regarding the switch up, Aurora CEO Roope Takala told TechCrunch that “in light of Momentus’ difficulties, we had to re-manifest the satellite onto the now published Rocket Lab flight.” Aurora announced in March it had signed on to launch a satellite with Momentus in June 2022.

A California-based medical startup that provides COVID-19 testing across Los Angeles has pulled down a website it used to allow customers to access their test results after a customer found a vulnerability that allowed access to other people’s personal information.

Total Testing Solutions has ten COVID-19 testing sites across Los Angeles, and processes “thousands” of COVID-19 tests at workplaces, sports venues, and schools each week. When test results are ready, customers get an email with a link to a website to get their results.

But one customer said they found a website vulnerability that allowed them to access other customers’ information by increasing or decreasing a number in the website’s address by a single digit. That allowed the customer to see other customers’ names and the date of their test. The website also only requires a person’s date of birth to access their COVID-19 test results, which the customer who discovered the vulnerability said “wouldn’t take long” to brute-force, or simply guess. (That’s just 11,000 birthday guesses for anyone under age 30.)

Although the test results website is protected by a login page that prompts the customer for their email address and password, the vulnerable part of the website that allowed the customer to change the web address and access other customers’ information could be accessed directly from the web, bypassing the sign-in prompt altogether.

The customer passed on details of the vulnerability to TechCrunch to get the vulnerability fixed before someone else finds it or exploits it, if not already.

TechCrunch verified the customer’s findings, but while we did not enumerate each result code, through limited testing found that the vulnerability likely put around 60,000 tests at risk. TechCrunch reported the vulnerability to TTS chief medical officer Geoffrey Trenkle, who did not dispute the number of discovered tests, but said the vulnerability was limited to an on-premise server used to provide legacy test results that has since been shut down and replaced by a new cloud-based system.

“We were recently made aware of a potential security vulnerability in our former on-premises server that could allow access to certain patient names and results using a combination of URL manipulation and date of birth programming codes,” said Trenkle in a statement. “The vulnerability was limited to patient information obtained at public testing sites before the creation of the cloud-based server. In response to this potential threat, we immediately shut down the on-premises software and began migrating that data to the secure cloud-based system to prevent future risk of data breach. We also initiated a vulnerability assessment, including the review of server access logs to detect any unrecognized network activity or unusual authentication failures.”

Trenkle declined to say when the cloud server became active, and why the allegedly legacy server had test results as recently as last month.

“Currently, TTS is not aware of any breach of unsecured protected health information as a result of the issues with its prior server. To our knowledge, no patient health information was actually compromised, and all risk has been mitigated going forward,” said Trenkle.

Trenkle said the company will comply with its legal obligations under state law, but stopped short of explicitly saying if the company plans to notify customers of the vulnerability. Although companies aren’t obliged to report vulnerabilities to their state’s attorney general or to their customers, many do out of an abundance of caution since it’s not always possible to determine if there was improper access.

TTS chief executive Lauren Trenkle, who was copied on an email chain, did not comment.

As many companies shift to a hybrid approach to work where some folks are working in the office and some at home, it’s easy for the home-based workers to feel a disconnect, even with video conferencing tools like Zoom. Video Window is designed to give users a feeling of being connected to other offices as though you were looking through a virtual window. Today, the company introduced a companion app for iOS and Android called Video Window Remote aimed squarely at those remote employees.

As the name implies, the latest addition to the Video Window family is designed to involve not just intra-office remote communication, but also include those employees who are working offsite, whether at home or in another location, and make them feel like they are in the office.

While video conferencing allows you to meet virtually to discuss the business of your work, it doesn’t give that connection that you feel of being in the office and chatting with your colleagues. That can sometimes lead to feelings of isolation or that your ideas are not being heard.

With Video Window Remote, users download the app to their phone or tablet and use that as a visual connection to the office, getting both video and audio as desired. This gives the water cooler experience that many remote workers feel they are missing by not being in the office.

Company CEO Daryl Hutchings says he came up with many of the features in Video Window Remote based on his own experience working at home during the pandemic. “Using Video Window is exactly like looking through a window to see your colleagues. It enables you to really be present with the people you work with while successfully completing your projects and accomplishing your goals, making work better, more enjoyable, fun and leveling the playing field for all. Ultimately creating a happy hybrid workplace,” Hutchings said in a statement.

In case you are concerned about security or privacy with a tool like this, Hutchings says that he built in several safeguards including preventing guest access, audio and video off by default (you control when you want to be seen and heard), the ability for everyone to see who is present regardless of their video/audio status, and scheduled sleep mode, so the service only turns on during scheduled hours.

The tool is available for free starting today from the iOS and Android app stores.

Swing Therapeutics, a digital therapeutics startup, has received an FDA breakthrough device designation for their 12 week smartphone-assisted fibromyalgia management program. This is the company’s first breakthrough designation, and precedes a deluge of clinical trials scheduled for this year. 

Swing Therapeutics was founded in 2019 and has raised a total of $9 million in seed funding led by JAZZ Venture partners. The company is focused on managing chronic pain, and specifically fibromyalgia.

This FDA breakthrough designation was awarded to the company’s smartphone adaptation of an acceptance and commitment therapy (ACT) program originally designed and tested at the University of Manitoba. Swing Therapeutics has exclusively licensed the program, and adapted it to form their own phone-based version. 

“We basically used [The University of Manitoba program] as a basis for our program and then really built on top of it, and adapted it to a sort of experience that would work great for a modern day smartphone interface,” says Mike Rosenbluth, the founder and CEO of Swing Therapeutics. 

This FDA designation will allow Swing Therapeutics expedited review at the FDA as the company conducts a series of clinical trials on the product.

At the moment, there is no cure for fibromyalgia, but the FDA has approved three drugs that can help manage symptoms. Those include: Lyrica, which is usually prescribed to treat nerve damage, but is also used to treat fibromyalgia; Cymbalta, which was originally developed to treat depression, anxiety and diabetic neuropathy; and Savella, an SSRI that’s similar to treatments for depression. 

Outside of the drug world, there’s some evidence ACT can help patients who live with chronic pain (including fibromyalgia). 

One meta-review of 25 studies on ACT and chronic pain, for instance, found that ACT therapy had small effects on pain intensity. But the therapeutic process of teaching patients to accept their pain (but not ignore it) was linked with moderate and long-term improvements in depression, anxiety and quality of life. 

“What ACT does is it tries to help people accept those symptoms and things that are uncontrollable. It helps people think about their values – what is really important to them,” says Rosenbluth. “And then they try to make behavior-based changes aligned with those values.” 

In that vein, Swing Therapeutics’ platform is designed to be prescribed by a doctor as a treatment management tool. Once prescribed, the patient would enter a 41 session acceptance and commitment therapy program that’s run entirely on their phone, and broken into “daily doses.” A “daily dose” might include a prompt for a mindfulness session or a short writing prompt. 

The University of Manitoba program that Swing’s smartphone program is based on does have a randomized controlled trial to its name. It was initially validated in a study on 67 participants who either received treatment as usual or their regular treatment plus ACT delivered via an 8-week online course. 

Completing the course was linked with improvements in depression symptoms and improvements in patients’ scores on the Fibromyalgia Impact Questionnaire (FIQ-R), which measures the effects of fibromyalgia on sleep, pain perception fatigue, or psychological distress.  The course appeared to help patients improve their “pain acceptance” and through that mechanism the experience of fibromyalgia. 

Importantly, the Swing Therapeutics program does differ slightly from the University of Manitoba program – namely, it’s designed for almost daily use, over 12 weeks on a smartphone, as opposed to 8 weeks on a computer. Even these small changes warrant their own independent clinical trials to ensure this approach also helps fibromyalgia patients benefit from this specific ACT therapy program. 

Swing Therapeutics has several of these clinical trials at different stages. 

This spring, Swing completed enrollment of a 67-person pilot study on their adapted treatment for fibromyalgia (patients were assigned to an active control or the ACT digital therapy). This study is ongoing. Last week, Swing also launched a large-scale study called REACT-FM. This study, currently recruiting, aims to enroll about 100 to 150 patients who will use the ACT product for two weeks. 

Finally, the company is also in the development phase for a Phase 3 randomized controlled trial. After completion of that study, the company plans to submit to the FDA for full approval of the platform. That study, says Rosenbluth, is planned to launch at the end of the year. 

The FDA breakthrough therapy designation has already helped shape these studies. As the trials continue, this designation means the device will continue to enjoy expedited review, which could smooth the platform’s journey through clinical trials. 

“We found it really useful to be able to have that channel dialogue with the FDA, so that we can make sure that we’re aligned in clinical study design and our approaches are in line with things that the FDA expects,” Rosenbluth says.