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Articles from 2018 In December

What Will 2019 Bring for Medtech?

Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality while reducing costs, this year we saw medtech respond with new solutions for improving care, expediting it, even bringing it to the home. New medical devices and diagnostics—particularly digital health technologies—are enabling patients to participate more in their own care. And providers are starting to put disrupters such as artificial intelligence and robotics into action in hopes of improving efficiency and outcomes.Such healthcare shifts are occurring at a time of regulatory change, given the European Union’s Medical Device Regulations (MDR) and FDA’s potential revamp of the 510(k) process.To predict how 2019 could unfold, MD+DI looked back over 2018’s progress. We also checked in with a few healthcare and medtech experts for their perspectives. We’d love to hear your predictions, too, so please comment below or email [email protected] a live discussion on what medtech can expect in 2019, MD+DI News Editor Amanda Pedersen moderates the panel, “What’s in Store for Medtech in 2019?” at MD&M West on February 5.  The panel will include Mike Devereaux, partner and director of manufacturing, distribution, and plastics industry services, Mueller Prost; Bryan O'Byrne, chief of international affairs and trade policy, U.S. Small Business Administration; Yarmela Pavlovic, partner, Hogan Lovells; and Vicki Barbur, senior director, IP and technology commercialization, commercial business, Battelle.

Edwards Heats up TAVR Market with New Approval

Pixabay Edwards Heats up TAVR Market with New Approval

Edward Lifesciences’s long-awaited Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System has received a nod from FDA. The Irvine, CA-based company had received CE mark for the valve in November.

The Sapien 3 Ultra valve features a heightened outer skirt designed to eliminate paravalvular leak. The new delivery system introduces an "on balloon" design, removing the need for valve alignment during the procedure.

"The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of Sapien 3 to further advance and improve patient care," Larry Wood, Edwards' corporate vice president, transcatheter heart valves, said in a release. "We look forward to introducing the Sapien 3 Ultra system to U.S. patients."

Edwards has been in a legal spat with Boston Scientific over elements of the Sapien 3 Ultra Valve for quite some time now. Back in October, a court in Germany ruled that the Sapien 3 Ultra had infringed on a patent that was originally established by Boston Scientific’s Symetis. The Marlborough, MA-based firm acquired Symetis in 2017 for $435 million.

The German court ruled in a preliminary injunction that Boston Scientific has the right to enjoin Edwards and its Germany subsidiary from offering and selling Sapien 3 Ultra in Germany.

Edwards said in an email sent to MD+DI on Friday that it has already begun a “controlled introduction of the Sapien 3 Ultra system in Europe except for Germany,” where it is enjoined. Edwards is disputing the ruling, which could come before the German courts in mid-2019.

However, the ruling does not impact the firm’s ability to launch the technology in the U.S., where it will do so in a controlled introduction, as soon as possible.

At the Heart of the Matter

The TAVR market is growing and there are more competitors coming on the scene that could offer a challenge to Edwards, which recognized as the TAVR pioneer.

Boston Scientific’s Lotus Edge is expected sometime in 2019 – which could provide direct competition to both Edwards and Dublin-based Medtronic, which have devices approved both in the U.S. and Europe.

In addition, there are smaller companies making strides in the TAVR market, such as JenaValve. The Irvine, CA-based company won a nod from FDA for expanded IDE enrollment for the Pericardial TAVR System with the Everdur transcatheter heart valve in early December.

The measure expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk. And in March, Colibri Heart Valve LLC began a feasibility study of its second-generation TAVR system.

But despite the growing competition, Michael Mussallem, Edwards’ chairman and CEO reassured investors during a recent earnings call that the company had strong product offerings in TAVR to maintain a healthy position in the market.

“And so, the question comes back to share, but it’s share of a rapidly growing market and we’re pretty confident in our position,” Mussallem said during an earnings call, according to a Seeking Alpha Transcript. “I mean, it’s absolutely true that we’re going to have new competition, but at the same time 2019 is going to the first year that we have real impacts from our Ultra valve and Centera.”

Obalon Scores Funding on the Heels of Obesity Market Shift

Pixabay Obalon Scores Funding on the Heels of Obesity Market Shift

Two new funding deals could give Obalon the added firepower needed for it to more effectively compete in the obesity treatment market. The San Diego-based company said it has garnered $30 million from a stock purchase agreement with Lincoln Park Fund and an At-the-market equity sales agreement with Canaccord Genuity.

The agreement with Lincoln Park Fund would net up to $20 million while the firm’s agreement with Canaccord Genuity could help bring in about $10 million.

Obalon said it could use the proceeds for sales and marketing costs, clinical studies, research and development costs, manufacturing development, the acquisition or licensing of other businesses or technologies, repayment and refinancing of debt, working capital and capital expenditures.

The company has FDA approval for a swallowable intragastric balloon system for the treatment of obesity.

Obalon’s financing comes right on the heels of some pretty remarkable shakeups in the obesity treatment market. Two of the firm’s rivals, ReShape Medical and Apollo EndoSurgery underwent a deal that would allow for a product swap of sorts.

In the transaction, Apollo said it would sell its surgical product line, which includes the Lap-Band adjustable gastric banding system to its rival ReShape Medical. In addition, ReShape decided to sell its intra-gastric balloon line to Austin, TX-based Apollo. The transactions are worth about $17 million.

In August, BAROnova made steps to enter the obesity treatment market in the U.S. and filed a premarket approval application to FDA for the TransPyloric Shuttle (TPS) device.

The San Carlos-CA based company’s technology is an intragastric implant that is trans-orally placed into the stomach during a standard endoscopic procedure. The device was designed to reside in the stomach for 12 months before being removed with another endoscopic procedure. During those 12 months, the device works to delay gastric emptying, a frequently used mechanism for weight loss that helps patients feel full much quicker during meals.

AI Aids in Detecting Multiple Conditions with One Chest CT

AI Aids in Detecting Multiple Conditions with One Chest CT
Image courtesy of Infervision

A new technology that works with existing computed tomography (CT) is aimed at reducing radiologist workflow and ultimately saving patient lives by enabling doctors to provide earlier diagnoses.

“The InferRead CT Chest scan is a AI-based algorithm that can automatically detect and characterize pulmonary nodules from chest CT scans,” said Yufeng Deng, chief scientist and director of Infervision North America, in an interview with MD+DI.

“The system is able to look through a CT scan, which is typically 300-400 slices, and look at pulmonary nodules from each slice and tell the radiologist where they are, and provide other information about these pulmonary nodules,” he continued. “It can detect size, diameter, volume, the slice number where the nodule is, which part of the lung the nodule is in, and how malignant or what are the chances of this nodule being cancerous.”

Recently, the platform has added capabilities to detect three more conditions, using a single chest CT. These conditions include pulmonary artery calcification, bone fracture, and chronic obstructive pulmonary disease (COPD.) “We want to expand our capabilities in reading chest CT scans, so it can do multiple things on same scan,” said Deng. “Because when a radiologist looks at a chest CT scan, he or she doesn’t only look at the lungs. The doctor wants to look at a few things.”

The platform takes images from the CT scanner after the procedure is completed using digital imaging and communications in medicine (DICOM) standards, or it can also connect to a picture archiving and communication system (PACS). “After our processing, we have our own user interface to display the information to the radiologist at their work station,” said Deng. “Or we can connect to their PACS, where the radiologist can view the images.

“This is an aid-in-detection tool,” continued Deng. “We’re not trying to replace the doctor, but we are trying to save their time to point their attention to a suspicious finding. For example, for a lung nodule, we are going to highlight an image where we think the lung nodule is so the radiologist can look at that and make a final decision.”

Above: The InferRead CT Chest can detect nodule size, diameter, volume, and more, reported Yufeng Deng, chief scientist and director of Infervision North America.

The platform’s effectiveness was recently demonstrated in a clinical trial. “We gathered several hundred CT scans and we let a group of radiologists read the scans to find pulmonary nodules on these scans,” said Deng. The experiment was repeated twice—the first time the radiologist read these scans on their own. A month later the same group read the scans again, but this time with the help of InferRead CT Chest. “We found with the use of InferRead CT Chest, the overall sensitivity of detecting pulmonary nodules increased and the reading time of each CT scan decreased,” said Deng.

The platform is currently in the approval process in the United States and in Europe. It is being used in 250 locations in China and in approximately 30 trial locations in the United States, Japan, and Europe.

Latest Boston Sci Deal Shakes up Mitral Repair Market

Pixabay Latest Boston Sci Deal Shakes up Mitral Repair Market

Boston Scientific is slipping in one more deal (maybe?) before 2018 ends, and it could have significant implications. This time out, the Marlborough, MA-based company will gain a stronger foothold in the transcatheter mitral repair and replacement market by exercising its option to acquire the remaining shares of Millipede Inc.

The deal will have Boston Scientific doling out $325 million with a $125 million payment becoming available upon achievement of a commercial milestone. The Millipede acquisition is set to close prior to the end of 1Q19.

Boston Scientific’s latest acquisition target is developing the Iris Transcatheter Annuloplasty Ring System for the treatment of patients with severe mitral regurgitation (MR), who are not able to tolerate open-heart surgery.

In an email sent to MD+DI, Boston Scientific said it believes “both transcatheter mitral repair and replacement are high-growth segments, as there is a large and currently underserved patient population with severe MR that has compromised heart function and is thereby unable to tolerate open-heart surgery to repair or replace the leaking valve.”

The company went on to say that, “transcatheter mitral remains a significant potential market opportunity, and there’s ample runway for it to position itself as a category leader in this space, particularly with the features of the IRIS device which are designed to have applicability across a wide range of patient populations.”

Mike Matson, an analyst with Needham and Co. LLC,  wrote in research notes that the IRIS transcatheter annuloplasty ring system can accommodate both tricuspid and mitral valve repair, which can open up opportunities for Boston Scientific.

“Given Millipede’s clinical focus on mitral valve repair, we expect Boston Scientific to focus more on the mitral application but see potential TAM upside with tricuspid optionality,” Matson wrote in research notes.

The IRIS system uses a complete annuloplasty ring to reduce the size of a dilated mitral annulus. Millipede’s Iris is delivered via a transcatheter-transseptal delivery system, and can be used as a stand-alone device, or in combination with other technologies in patients with severe MR.

"Upon commercialization, we believe the IRIS system can meet the needs of a currently underserved patient population that requires physiological, less invasive options to treat functional mitral regurgitation in patients with progressive heart failure," Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific, said in a release. "This device is designed to be highly customizable to a specific patient's mitral anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome."

The deal shouldn’t be surprising because in January of this year, MD+DI reported Boston Scientific had taken a $90 million stake in Millipede and could acquire the Santa Rosa, CA-based company within the next year or two.

This isn’t the first mitral repair company Boston Scientific has invested in. Back in December of 2016, Boston Scientific made some key investments into Neovasc. However. Matson said that Millipede is a much better deal for Boston Scientific than Neovasc at this point. Neovasc has struggled to make earnings expectations this year and saw its shares drop after it missed the mark in 3Q18.

“While there are still clinical, commercialization, and integration risks and Boston Scientific is paying a high price for Millipede, we believe this transaction could lay the foundation for the mitral leg of Boston Scientific’s Structural Heart franchise, particularly given Neovasc’s issues,” Matson wrote in a research note.

Is the Millipede Acquisition Right on Time?

Boston Scientific, which was named Editor’s Choice for Medtech Company of the Year in part because of its significant M&A activity (10 deals in 2018!), said the transcatheter mitral valve and repair market is estimated to reach about $1 billion by 2021.

But is Boston Scientific too late to hop on the transcatheter mitral repair and replacement party, or is the company right on time? In 2015, many of Boston Scientific’s larger competitors began buying up smaller mitral valve repair companies.

Edwards Lifesciences, a pioneer in the transcatheter valve replacement (TAVR) market, set the tone for the 2015 mitral valve buying spree, by spending up to $400 million to acquire CardiAQ Valve Technologies and its transcatheter mitral valve replacement (TMVR) system.

In 2016, Edwards would go on to acquire Yehuda, Israel-based Valtech Cardio Ltd. for about $340 million, with about $350 million in milestone payments.

Shortly after Irvine, CA-based Edwards made its intentions clear for the market in 2015, Abbott Laboratories announced it would acquire Tendyne, a maker of a TMVR system, for about $250 million. The Abbott Park, IL-based company followed up with an unspecified investment in Cephea Valve Technologies, with an option to buy the firm down the road.

Medtronic followed suit in the 2015-buying-spree by putting up $458 million for Redwood, CA-based Twelve Inc.

Key Trial Developments

Boston Scientific will have to contend with many of the players in the space moving into key parts of their clinical trials.

Most recently LivaNova, a company that has been in the process of reinventing itself since 2017 concluded its PRELUDE feasibility study of its Caisson TMVR system. The London-based company said in August that it would turn its efforts toward enrolling patients into its INTERLUDE CE mark trial and finalize the protocol for, ENSEMBLE, the U.S. pivotal trial.

During this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference, Or Yehuda, Israel-based Cardiovalve announced it would launch the AHEAD US Multicenter Study. The company also presented details of the first-in-human procedure with the transfemoral mitral valve system during TCT.

In July of 2018, Abbott initiated SUMMIT, a 1,010 pivotal study of the Tendyne TMVR system. In an email, sent to MD+DI shortly after the SUMMIT announcement was made, Abbott said enrollment in the study was anticipated to be completed within four years and the primary endpoint would be evaluated at one year, with total patient follow-up being in five years. The firm said regulatory submission is expected one year following the trial conclusion.

CDx Diagnostics Continues to Shine with Strong Data

Courtesy of CDx Diagnostics CDx Diagnostics Continues to Shine with Strong Data

A newly published study of CDx Diagnostics’s WATS3D, which employs artificial intelligence (AI), continues to show the effectiveness of the test for the detection Barrett’s esophagus. The nearly 13,000-patient study was published in Diseases of the Esophagus. The results come right in the middle of the AI Renaissance that is occurring in healthcare.

The Suffern, NY-based company’s published data showed that the addition of WATS3D to standard targeted and random forceps biopsy (FB) markedly increases the overall detection of esophageal dysplasia by 242% and the overall detection of Barrett’s esophagus by 153% in patients undergoing screening and surveillance.

“The [study results] are a validation of what we have known for a long time,” Michael S. Smith, MD, MBA, lead author and Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke's Hospitals in New York City, told MD+DI. “And that is the four quadrant Seattle protocol forceps biopsy method of following a patient who has Barrett’s or examining a patient where there is concern for Barrett’s is simply an inadequate approach to managing this disease.”

He added, that through WATS3D there is a better way to “effectively monitor and follow this precancerous condition of the esophagus that goes well beyond what have been doing to follow it for quite some time.”

WATS3D received a nod from FDA in 2012 and was launched in 2014. The imaging component of the test has roots in a 3-D imaging system based on an algorithm from President Ronald Reagan’s U.S. Strategic Defense Initiative, known as the Star Wars program.

WATS3D works by collecting a more varied sample of tissue than individual pokes using forceps and collects more samples to analyze than cytology. These are then analyzed in 3-D throughout the entire sample to spot any signs of disease. With WATS3D, the physician uses a stiff-bristled brush to scrape around the esophageal wall in an up-and-down motion. The brush allows for more and deeper sampling than forceps.

“What’s different … is the idea that we’re going to be using neural networks and artificial intelligence as a way of identifying the troubled tissue,” Smith said. “Using that enhancement technology which is not at the point-of-care, but behind the scenes when the specimen is processed and evaluated, is something that people are going to have to get used to. With that being said, if you ask gastroenterologists now, and certainly in our professional meetings, and in our journals, they are certainly hearing about AI all the time, and using computer-assisted technology to care for our patients. So being able to utilize that in the management of a pre-cancerous condition seems like a great benefit.”

In-Home Healthcare Is Here to Stay–and That’s Good News

A century ago, house calls were the norm in the medical industry. But gradually, as populations grew and medical technology advanced, in-home healthcare declined in favor of office visits, which allowed for a higher volume of patients and easy access to the latest equipment. By the 1940s, less than half of doctor visits were house calls, and until recently, the number continued to decline. In the last decade, however, in-home healthcare has been steadily rising, a trend that is likely to shift the healthcare landscape drastically. For medical devices manufacturers, that’s a good thing.

When it first reemerged, in-home healthcare was known as concierge medicine—a premium service that few people could afford. But a recent study suggests that for many patients, in-home healthcare may actually cost less in the long run than office visits.

In 2012, the Centers for Medicare & Medicaid Services launched the Independence at Home demonstration to evaluate in-home medical care in terms of success rate and cost. The program, which focused on 10,000 chronically ill Medicare patients, included 17 medical practices. In addition to providing in-home primary care, the practices were also required to maintain a mobile electronic health record for each patient and visit patients within 48 hours of discharge from a hospital or emergency room. The goal of the demonstration was to deliver personalized medical care, improve patient experience, and reduce Medicare costs by decreasing ER visits, hospitalizations, and 30-day readmission rates. That’s exactly what happened.

Ultimately, the demonstration reduced Medicare costs by 30% and yielded more than $35 million in savings. Across the board, ER visits, hospitalizations and 30-day readmission rates were reduced. The program was extended for another two years in 2015 and again in 2018. Experts predict that a nationwide IAH program could serve up to two million Medicare patients with chronic illnesses and disabilities—and yield $10 billion to $15 billion in savings over the next 10 years.

Other studies have reported similarly encouraging results. A 2017 study from Indiana University’s Center for Aging Research and the Regenstrief Institute found that recently discharged patients who received in-home healthcare were less likely to be readmitted to the hospital within 30 days than patients who visited an outpatient provider after discharge.

Encouraged by findings like these, companies around the country are investing in mobile medicine. Apps like Heal and Pager allow patients to use their smartphones to schedule house calls with a licensed physician. Medical centers, insurance companies, and individual healthcare providers are also jumping on the bandwagon; many are establishing practices that specialize exclusively in house calls.

Medical device manufacturers are also getting the message, particularly when it comes to portable medical devices. As healthcare delivery becomes increasingly mobile, portability is more critical than ever before in device design and engineering. To be sure, portable medical equipment (PME) is already big business; the industry generated $27.8 billion globally in 2017. But with aging populations living longer than ever before—and an increased emphasis on quality of life—the demand for in-home care and, as a result, portable equipment is poised for astronomic growth. In fact, recent estimates suggest that PME revenue could climb to upward of $50 billion by 2024.

This trend comes at a time when advances in both technology and manufacturing are allowing for the development of precise medical equipment and tools that are smaller, more lightweight, and more cost-effective than ever before.

This shift will give medical device manufacturers a unique opportunity for growth. If mobile healthcare is destined to become the norm rather than the exception, everything from dialysis and MRI machines to transcutaneous electrical nerve stimulation systems will need to be easily portable and impervious to the everyday bumps, drops, and vibrations that are inevitable in mobile transport. Customized reusable packaging—and the durable protection and portability it provides—will be the gold standard for the new era of modern mobile healthcare.


Los Angeles Times (

Independence At Home (

Modern Healthcare (

Essure Discontinuation Doesn't Mean the End to FDA Scrutiny

Image Credit: MD+DI/Amanda Pedersen Essure Discontinuation Doesn't Mean the End to FDA Scrutiny

FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues to be studied even after U.S. sales of the device are discontinued at the end of the year. While this seems like a good idea, in theory, patient advocates have concerns about the validity and feasibility of the required post-market study.

Bayer announced in July that it would stop selling the Essure device at the end of the year due to a decline in U.S. sales. FDA Commissioner Scott Gottlieb said at the time that the agency would still hold the company responsible for meeting its postmarket obligations concerning the device, which includes a postmarket study to assess the long-term safety of the product. This week the agency took the additional step of making Essure a restricted device, even though the company plans to discontinue sales.

The agency also is making Bayer study patients out to five years, rather than the three years that was initially required. The extension will provide FDA with longer-term information on adverse risks of Essure, including issues that may lead women to have the device removed, Gottlieb said in a statement issued this week.

FDA is also requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. "This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure," Gottlieb said.

However, the agency also said it realizes that Bayer may not be able to enroll enough patients in the required study, given the decline in sales and the company's decision to pull Essure from the market at the end of the year. FDA is allowing a reduction in the number of required patients in the study. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm). The initial sample size relied on enrolling patients who were newly implanted with Essure until May 2020.

"We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment," Gottlieb said.

The E-Sisters are not so sure about that though.

"We knew that Bayer meeting the enrollment requirement was going to be a significant issue as awareness about the dangers of the Essure device is everywhere now, especially since the Netflix release of The Bleeding Edge," the patient advocacy group said Wednesday in response to the new study requirements. "While we agree with the FDA in taking steps to lengthen the time frame from three to five years and ordering more specific blood tests to look at autoimmunity, the fact of the matter is that Bayer is still running the show and has a vested interest in providing favorable results."

The Essure Problems group is particularly concerned about the significant drop in enrollment numbers of Essure patients under the revised protocol.

"So, yet again, the sample size of women implanted with Essure in this study will be small. We do not understand why the FDA continues to bend over backward for industry while women continue to be implanted and potentially harmed without holding Bayer accountable. They have the authority to order all Essure kits off the shelves while women that have already been implanted are independently evaluated and studied, yet refuse to do so."Gottlieb said he has heard these women's concerns, however, and is taking the matter seriously.

"I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health."

Beta Bionics Wins Readers' Choice for Medtech Company of the Year

Courtesy of Survey Monkey Beta Bionics Wins Readers' Choice for Medtech Company of the Year

The people have spoken. Beta Bionics has been named medtech company of the year. Nearly 44% of MD+DI readers participating in a special poll voted for the Boston, MA-based company, which is developing an artificial intelligence-powered bionic pancreas, called the iLet, to help manage type 1 diabetes. Beta Bionics pulled ahead of other competitors like Boston Scientific, which was MD+DI Editor’s Choice for medtech company of the year.

Each year, MD+DI's editors take a long, hard look at the medical device and diagnostics companies that rose above the ranks over the past 12 months. It can be savvy business strategies, breakthrough products, or operational execution that set the best of the best apart.

Beta Bionics has been making significant strides in the diabetes management landscape by scoring an IDE and a plush partnership with Senseonics Holdings.

“This is really is a cherry on top of a wonderful cake that we’ve had which is 2018,” Edward Raskin, vice president of business development and a board member at Beta Bionics, told MD+DI. “This is the year we’ve been recognized by the industry along with the community and have been in clinical trials doing our working studies as we lead into our pivotal trials in 2019. This is just an incredible feeling to march through so many achievements.”

Beta Bionics’s iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. The body-worn device contains a little cartridge with insulin in it. The device is connected to the body through a tube with insulin. There is also a two-hormone version of the technology, so it can be configured to use insulin or glucagon.

Embedded in the system are clinically tested mathematical dosing algorithms driven by machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. Once initialized, the iLet engages its machine-learning, AI to autonomously control the individual’s blood-glucose levels, and to continuously adapt to the individual’s ever-changing insulin needs.

“We’ve built a device that learns in real-time continuously,” Ed Damiano, CEO and founder of Beta Bionics, told MD+DI. “iLet adapts to your ever-changing insulin needs and adjusts them for you automatically – kind of how a self-driving car can get you from a to b without you participating in that process.”

The company has a “lean” team that operates on two coasts to accomplish its goals. With under 30 people on staff, Beta Bionics has its core manufacturing operations, along with business development and legal action in Irvine, CA. In Boston, the company’s operations include but are not limited to clinical and regulatory.

If Beta Bionics can get approval and, on the market, there will definitely be comparisons between the iLet and Medtronic’s MiniMed 670G Insulin Pump, which has been dubbed the artificial pancreas. The Dublin-based company received a nod from FDA for the artificial pancreas in 2016.

But despite the potential comparisons and thoughts on competition, Beta Bionics said that just won’t be the case, especially since many of the firm’s team have family members or are impacted by type 1 Diabetes. In fact, the company said it is focused on developing an ecosystem of treatment or patients.

“We come from the type 1 diabetes community,” Raskin said. “I have a kid with type 1 and (Damiano) is in the same boat, and many people in the company have type 1 themselves. We’re strong believers that advances in technology in this space sort of floats our boats. So, when Medtronic succeeds; when we succeed; when BigFoot succeeds; it helps everyone in the community in one way or the other.”

Part of the appeal of Beta Bionics comes from its community-like feel. In 2016, the company did a regulation crowdfunding and raised $1 million - the maximum amount allowable. Many of the people that supported the crowdfunding effort had been impacted by diabetes.

Even in MD+DI’s reader’s poll, normal everyday people, outside of the industry chimed in and supported the bionic pancreas developer.

“I am a school nurse,” an anonymous voter wrote. “Monitoring kiddos with diabetes is challenging at school. This device could be life changing for them! Thank you!”

Another anonymous voter wrote, “I am a person with and mother of a 12-year-old battling type 1 diabetes who is closely following the advancements coming from Beta Bionics and believe them to be capable of bringing life-changing technologies to the market for millions with type 1.”

“Ed Damiano is a true inspiration and has taken his own family experience with type 1 diabetes, and turned it into hope for many, many sufferers,” one voter wrote. “His ingenious innovation is only usurped by his generosity, in creating Beta Bionics in a way that will serve patients around the world above profit.”

With a successful 2018 under their belt, company executives are now looking forward to an eventful 2019.

“I think the probably one of the most exciting things you’ll see in the early part of 2019 are the top line results from our summer study that we completed using our clinical version of iLet,” Raskin said. “This will be a major milestone. The most exciting part of 2019 will be the submission of our IDE for a pivotal trial and the actual first steps in launching that trial.”

“While all of this clinical work is going to be going on with our pre-commercial units that [Raskin] referenced will be going on in the first half of 2019 and into the middle … we’ll be building out the final commercial platform and doing the final benchtop testing of it for preparation of submitting the application to FDA for a final registration trial of the device,” Damiano told MD+DI. “We’re also at the same time going to be building out the manufacturing capability in Irvine. Despite all this product development we’re doing in 2019 we’re still doing [leading] edge research with the device."