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The annual AdvaMed conference, rebranded "Medtech Conference" this year, drew more than 2,700 attendees seeking to explore cutting-edge technologies and networking opportunities, as well as to hear from FDA's top officials about new developments. This article takes a closer look at some of the most innovative solutions presented at the event, including machine learning-based diagnostics to combat antimicrobial resistance, a ureter-locating device, virtual reality technologies to enhance orthopedic surgery and precision drug dosing, among other things.

 

 

precision Drug Dosing 

 

 

Veteran industry experts and the bright young minds they mentor were among the 2,700 attendees at the 11th annual Medtech Conference, organized by medtech trade association AdvaMed and held at the San Jose McEnery Convention Center on Sept. 25-27.

 

 

This year's meeting featured 50 companies showcasing a diverse range of early-stage technologies such as in-vitro diagnostics, orthopedic products, therapeutic dosing technologies, cardio- and peripheral vascular devices and surgical tools. The presentations also included the four finalists of the 2017 Medtech Innovator $500K Competition, who were whittled down from 600 companies.

 

 

This articles delves deeper into the technologies of five of these showcasing companies, three of which were the Medtech Innovator finalists. It also includes a table listing of the other up-and coming developers of tomorrow's technologies.

 

 

Combatting Antimicrobial Resistance

 

Beating 600 other startups to win the $350,000 grand prize at the 2017 Medtech Innovator competition was Boston-based Day Zero Diagnostics, Inc., which is focused on developing IVDs for tackling antimicrobial resistance.

 

CEO and co-founder Jong Lee told the audience that had voted for the company to win that Day Zero is striving to be the dominant provider of data in the pathogen space.

 

The goal of the firm is to combine whole genome sequencing and machine learning (Also see "Artificial Intelligence Brings Wave Of Future Health Care Innovation – Embrace it or be Left Behind" - Medtech Insight, 28 Jul, 2017.) to develop a diagnostic to help accelerate the detection and identification of pathogens that are responsible for antibiotic resistance; and thus, help physicians triage patients with severe infections, in particular, sepsis, faster and more accurately.

 

 

"Our mission is to create a diagnostic that can take a clinical sample like blood, rather than blood culture, and give you a specific ID and resistance profile in five hours rather than five days, so that patients can be treated with the right therapeutic on the first day they are admitted to the hospital," Lee said.

 

 

Terry Harrison, attending physician, gynecology oncology at the Kaiser Permanente Medical Center in San Diego, California agreed that early diagnosis of these pathogens is often life-saving.

 

 

"It is critical to identify antibiotic susceptibility in critically ill patients with severe infections where minutes or hours may make a difference in terms of successful treatment and even survival," Harrison told Medtech Insight.

 

 

Thus far, the company has done proof-of-concept testing in more than 4,000 samples where they identified the species of the pathogen 100% of the time and achieved 95% accuracy on 39 classes of bug drug resistance, Lee said. The company has created a proprietary database through a licensing agreement with Boston-based Massachusetts General Hospital where they have collected 30,000 bacterial isolates that have different antibiotic susceptibility.

 

 

"We have all of their known phenotypic resistance profile and sequence the genomes of the pathogens," Lee said. What makes Day Zero Diagnostics different from other companies trying to identify bacterial susceptibility is the use of whole genome sequencing combined with machine learning (Also see "Antimicrobial Susceptibility Test-Makers Seek Ways To Shorten FDA Clearance Process" - Medtech Insight, 19 Sep, 2017.).

 

 

"By using machine learning to do our algorithm, we can essentially identify any known pathogen that's available in our database and predict resistance even for things that have not previously been seen," Lee said.

 

 

"By using machine learning to do our algorithm, we can essentially identify any known pathogen that's available in our database and predict resistance even for things that have not previously been seen," Lee said.

 

 

He said a lot of molecular diagnostics that use technologies like PCR in trying to identify bacterial susceptibility are limited in that they identify a limited number of pathogens in a sample and only one or two resistance genes.

 

 

"But they are not agnostic, meaning they use biased detection methods and they tell you almost nothing about resistance," he said. The company focuses on sepsis, because it represents the biggest unmet clinical need in hospitals with the average patient treatment cost being $10,000-$50,000. It is also the biggest economic opportunity for saving hospital costs. He said inpatient infectious disease identification and susceptibility testing is an estimated $5bn market.

 

 

Under the business model, Day Zero Diagnostics may provide hospital clients with the analyzer and charge per disposable, single-use cartridge and offer lab testing in-house where clients would send samples to the company, Lee said. The company also has plans to offer future hospital clients access to its data analytics model on a subscription basis.

 

 

"Every time someone runs our diagnostic, they generate a genomic sequence which goes into our database," Lee explained. "The database is grown by customer usage. We'll be able to provide hospitals with investigative services for hospital-acquired infections and regional surveillance data and help discover new targets for antibiotics as a result of machine learning algorithms."

 

 

For now, the company is still in its earliest stages. The windfall from winning the Medtech Innovator competition comes just one month after Day Zero Diagnostics completed a $3m series seed financing led by Golden Seeds and Sands Capital Ventures. All these funds will be used to support prototype development of the company's diagnostic platform, Lee said.

 

 

He added that it was too soon to give a timeline on when the device would be fully developed. He said the ultimate goal is to develop an in-vitro diagnostic with US FDA clearance.

 

 

Ureter Detection Made Easier

Innovations in surgical tools and planning continues to be a hot area in medtech and Allotrope Medical's founder Albert Huang hopes to be on the cutting edge of this sector with StimSite, a hand-held device designed to assist surgeons to identify the ureter, a tube that carries urine from the kidney to the urinary bladder, more easily and quickly during a surgical procedure.

 

 

The technology was attractive enough for the company to be the runner-up in the Medtech Innovator competition, which translated into a $50,000 prize.

 

 

A general surgeon by training, Huang said he realized the need first-hand for a better instrument to aid surgeons in identifying the ureter back in 2014. "Current ways to identify the ureter fall short," Huang said.

 

 

He told Medtech Insight he spent the next two years developing a prototype during his limited free time, experimenting with spare parts from electronic stores and talking to experts. When Allotrope Medical raised $350,000 in seed funding from Houston, Texas-based angel investors and Houston Health Ventures last fall, Huang decided to trade in his OR scrubs for a business suit to grow his company and try to bring StimSite to market.

 

 

"Current ways to identify the ureter fall short," Huang said.

 

 

The two technology-based methods – ureteral stent placement and using fluorescent systems – are expensive and not reimbursed by insurance providers. Ureteral stent placement, which is used in 20-30% of surgery cases, costs about $1,200 per patient; and using fluorescent technology is even more costly and it subjects patients to chemical injections, he explained.

 

 

The target market for StimSite is general gynecologists who perform the majority of hysterectomies -- 1 in 3 women will undergo a hysterectomy by the age of 60 -- as well as general surgeons performing minimally invasive surgeries such as laparoscopic colon resections -- 1 in 20 Americans will have colon cancer, which leads to an operation in many cases, Huang noted.

 

 

More than three million procedures are performed each year in the US where the ureter needs to be identified as a critical part of the operation. Injury to the ureter translates into a $3.2bn annual health care burden in the US, Huang said during his presentation.

 

 

StimSite is safe, simple and easy to use and fits seamlessly into the surgeons' workflow, according to Huang. The battery-powered, single-use device generates a safe and brief electrical impulse with a push of a button that makes the ureter contract and easy to identify.

 

 

Though Huang feels the device meets an urgent need, not all surgeons would agree.

 

 

Harrison told Medtech Insight he feels that a device is only rarely helpful or necessary to identify the ureter.

 

 

"It is true that ureteral injury is a serious complication of pelvic surgery, occurring in about 1-2% of hysterectomies," he said. "Legal claims and lawsuits often follow cases of ureteral injury."

 

 

Huang said that it costs hospitals a significant amount of unnecessary dollars when surgeons spent up to 30-40% of their operating time trying to identify the ureter, referring, in particular to laparoscopic colon resection surgeries.

 

 

But Harrison and another Kaiser gynecologist both feel that this claim is exaggerated.

 

 

"It usually takes less than a minute (to identify the ureter)," Harrison said. "Furthermore, it's relatively straightforward to identify the ureter in most cases. It continually undergoes peristalsis, or contracts, on its own. When it does not show the characteristic peristalsis, it is easily stimulated to contract by touching it with any standard surgical instrument, without an electrical pulse."

 

 

"It takes us minutes to find the ureter," echoed Rene Perez, an OB-GYN at Kaiser Permanente Medical Center in San Diego, California, who said he has performed hundreds of hysterectomies.

 

 

Huang said the device isn't targeted at specialists who operate daily, but more toward gynecologists who operate on fewer days of the week.

 

 

He agreed with Harrison and Perez that the ureter will naturally contract on its own. But he argued that in some cases, waiting for the contraction to visually confirm the location of the ureter takes time and during the dissection process injuries can happen.

 

 

"Stimsite elicits contraction, which is safer and more efficient, if the ureter isn't immediately identifiable or during surgery when physicians can't locate it in a rapid way," he explained.

 

 

Huang is currently in the process of trying to raise $3m in a Series A funding to finance animal studies to show efficacy and safety of the device's power profile compared to existing devices.

 

 

This would put the device on track for FDA 510(k) premarket submission in Q1 2019. StimSite would qualify for reimbursement under the Diagnosis Related Code (DRG), which Huang noted would be a fraction of the cost compared to current ureteral stent placement or fluorescent technology used to identify the ureter. He is also talking to investor groups and companies that would be interested in integrating StimSite into their portfolio.

 

 

"Our device can be easily adapted in robotics, but because the technology is focused on a power profile and a tip design, we can see it integrated into existing instruments and plugged into current electrosurgical tools and build into endoscopic technologies," he explained.

 

 

Table 1

Ones To Watch: Other Promising Early-Stage Companies at The Medtech Conference

 

Orthopedics: VR Training Platform

 

Two companies presenting at Medtech's orthopedic innovation showcase, though with entirely different technologies, were Osso VR and Myovue.

 

 

Justin Barad, a former game developer and practicing pediatric orthopedic surgeon, said he founded Osso VR to offer medical students and surgeons a training tool to perform "real" surgeries in the virtual world, aiming to reduce complication rates, help surgeons learn complex procedures faster and safer, and improve patient outcomes.

 

 

Palo Alto, California-based Osso VR raised $400k in pre-seed funding, led by Presence Capital's Amitt Mahajan last September and another $2m in seed funding from Signalfire with participation from Anorak Ventures this June.

 

 

Barad said Osso VR's technology meets a real unmet need, citing data from the medical literature that shows surgeons who adopt a new technology typically need to do 50 to 100 cases to gain proficiency.

 

 

"Up to that point, the complication or revision rate is 300% higher than it should be," Barad said.

 

 

A study conducted at UCLA’s David Geffen School of Medicine of eight medical student participants compared Osso's VR training with current training methods, using manuals and technique guides, showed that the VR group had twice the performance score vs. using traditional means when tested on a simulated bone model.

 

 

"For the first time, we're going to be able to shorten the learning curve and increase the adoption of newer medical technologies and surgical techniques," Barad said.

 

 

"For the first time, we're going to be able to shorten the learning curve and increase the adoption of newer medical technologies and surgical techniques," Barad said.

 

 

Osso VR is already being marketed to several top 10 orthopedic device companies, which Barad declined to name. Under the business model, Osso VR provides custom content for companies and a license that includes the hardware, analytics platform and support and training for the product, he explained.

 

 

Given that some $6.4bn is spent on training surgeons and sales reps, Barad said Osso VR's technology fills a significant need by improving patient outcomes and decreasing cost in this value-driven health care environment (Also see "Latest Mako Tech Fleshes Out Stryker's Robotic Joint Replacement Line But Cost Critics Still There" - Medtech Insight, 20 Mar, 2017.).

 

 

With VR and augmented reality (AR) being on the cutting edge of innovation, Osso VR is already exploring further applications of its technology to offer surgeons, Barad told Medtech Insight ((Also see "Virtual Reality: The New Game In Mental Health Care To Improve Outcomes" - Medtech Insight, 22 Jun, 2017.)).

 

 

For instance, VR may be used by surgeons to perform "mission rehearsals," which encompasses using the exact anatomy of a patient to prepare for a specific case prior to the actual surgery.

 

 

"In the OR, there is a whole suite of technologies that can be enabled with frontier technologies such as AR and VR," Barad said. In the near future, surgeons may be using Osso VR's technology to interface with other technologies to do video proctoring, track instruments, navigate, and more.

 

 

"In the OR, there is a whole suite of technologies that can be enabled with frontier technologies such as AR and VR," Barad said. In the near future, surgeons may be using Osso VR's technology to interface with other technologies to do video proctoring, track instruments, navigate, and more.

 

 

"Some of them we are exploring right now and some are further out in the future," Barad said about his technology platform. "These all work together to accomplish the same goal, which is taking a device or technique and making sure the patient gets the maximum benefit and outcome at minimum cost and complications. We're really just getting started in the training space, but we're looking to expand to all of these frontier technologies that we're incredibly expert at."

 

 

ACS Sensor

 

Meanwhile, Myovue's CEO, Charles Allan, hopes to break another frontier in the emergency department.

 

Allan co-founded Myovue with four partners in 2015 with licensed technology from McGill University in Montreal, Canada where he was a graduate student of bioelectrical engineering.

 

The device is designed for emergency department physicians to help diagnose Acute Compartment Syndrome (ACS).

 

 

Every year, some 500,000 trauma patients in the US are at risk for developing ACS, a potentially devastating diagnosis caused by high-energy trauma events, such as bone fractures. If undiagnosed, ACS that can lead to damaged nerves, muscles and vasculature. Compartment Syndrome can develop in several compartments throughout the body, but it is seen most commonly in the forearm and lower leg. If not undiagnosed and operated on within six hours, patients are at risk for permanent muscle and nerve damage; at 12 hours without diagnosis, it can lead to amputation, Allan told Medtech Insight.

 

 

If a patient presents with a fracture, the high-energy trauma that caused the fracture can cause swelling to build up in the adjacent muscle. Physical exams, such as the "pain out of proportion exam", in addition to testing pain with passive stretching of the involved compartment have proven to be unreliable and are often insufficient to establish a proper diagnosis, he said.

 

 

Allan claims that Myovue can help diagnose ACS immediately or within hours.

 

 

The device measures perfusion pressure by placing a small sensor within the muscle, similar to the way an IV is applied. The sensor quantifies the amount of swelling and relays the data to a cloud-based mobile app, which gives the physician the information needed to decide if and when to intervene with a fasciotomy, an emergency surgical procedure that cuts open the affected muscle to relieve pressure. Clinical data shows that whereby using a threshold for intramuscular perfusion pressure sustained at <30mmHg for 2 hours or more, the calculated sensitivity based on performing fasciotomies is 94% with an estimated specificity of 98%.

 

What sets Myovue apart from currently available diagnostics testing is that it provides physicians with a continuous, reliable, real-time pressure measurement.

"The sensor stays in the muscle, and thus, gives the surgeon a real-time number they can monitor continuously for up to 48 hours post-injury," Allan explained.

"The sensor stays in the muscle, and thus, gives the surgeon a real-time number they can monitor continuously for up to 48 hours post-injury," Allan said.

 

 

That is critical, because if the pressure rises during that time, the doctor needs to perform fasciotomy immediately to allow the pressure to return to normal and to save the limb from amputation.

 

A test for ACS that is widely used by physicians today is Stryker Corp.'s Intracompartmental Pressure Monitor System, which uses a saline-filled needle that is inserted into the appropriate compartment to measure pressure, Allan said. But he feels that this test isn't as accurate as it could be.

 

 

"The water comes up to the sensor and the sensor is outside the body, so depending on the angle of the sensor, it changes the value you'll get, often significantly."

 

 

Myovue's sensor integrates MEMS technology to measure pressure from directly within the muscle, which he believes is significantly more accurate and independent of the angle at which doctors hold the device.

 

 

Allan said he plans to run a preliminary clinical feasibility study on Myovue comprising 50 patients at four sites across Canada this December and hopes to use the study results to apply for CE-marking in May 2018.

 

 

Precision Medicine: Drug Dosing

Bradley Messmer, founder and CEO of Abreos Biosciences, finds in an era where so much focus is being given to precision medicine, it's unfortunate that precision drug dosing, or how much of a drug individual patients should receive to optimize treatment, doesn't get the same attention.

 

 

He is setting out to change that at Abreos.

 

Messmer first explored the critical need to optimize drug dosing as a faculty member at the Moores Cancer Center at UC San Diego. After realizing the potential for commercializing tests that would allow physicians to optimize how much of a biologics drug should be given to individual patients, he founded Abreos in October 2013. This June, he took on the CEO helm full-time and hopes to be on the market with a test next year.

 

Abreos was one of the four finalists in the Medtech Innovator competition.

 

Biologics, including antibody-based treatments for cancer and chronic autoimmune disorders such as multiple sclerosis, are far more expensive than their small molecule counterparts, Messmer told the audience at the event. A single dose can cost thousands of dollars, yet precise dosing and monitoring of biologics is still not a routine part in the clinic.

 

"When your drug costs as much as a Ferrari, it should at least come with a speedometer," Messmer said.

 

"When your drug costs as much as a Ferrari, it should at least come with a speedometer," Messmer said.

 

The company's core technology, Veritope, uses a proprietary reagent platform based on peptides to detect a given biologic or biosimilar drug by mimicking the natural drug target. That includes cell-membrane-bound proteins aiming to detect the biologic drug in serum or plasma. The tests are designed as both -- lab-based tests in hospitals and point-of-care tests, including at-home testing by consumers -- which Messmer said is the big differentiator between Abreos and other companies that offer precision dosing testing today.

 

 

Most companies focus on either POCT or lab tests, not both, which, he said, will give Abreos a competitive edge on the market (Also see "Voyage Into Point-Of-Care Testing Gets Deeper" - Medtech Insight, 16 Aug, 2017.).

 

 

The company expects that the first test to hit the market will be a lab test to help physicians determine the correct dosing for Tysabri, an immunosuppressant commonly prescribed for multiple sclerosis patients. The drug costs roughly $5,000 per monthly dose and is known to put patients at risk of developing progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to severe disability or death.

 

 

"Tysabri is dosed in a one-dose fits-all fashion, so 100-pound Mary (a patient who was part of a clinical trial the company conducted) and a 300-pound football player are given the exact same dose," he said, adding that's "impersonal medicine" given that each individual absorbs a drug differently.

 

 

Abreos has been collaborating with Rocky Mountain Multiple Sclerosis Clinic in Salt Lake City using its technology to measure drug levels in 200 patients treated with Tysabri. Messmer hopes to be able to market this test as a CLIA-waived test in 2018. CLIA-waived status from the FDA allows non-laboratory personnel to perform this test. Another planned clinical trial for 2018 would be for a developed point-of-care test in 200-300 patients taking the drug Remicade for treating inflammatory bowel disease.

 

 

To date, Abreos has raised $2.8m in funding, predominantly from angel investors and NIH small business innovation research grants, Messmer told Medtech Insight. This May, current investors funneled another $1.2m into Abreo's coffers for hitting a milestone to hold a pre-submission meeting with the FDA to discuss a de novo 510(k) pathway for developed tests, he added.

 

 

Next summer, Messmer hopes to raise another $5m-8m in a Series A funding round, which would allow the company to launch the test to optimize dosing for Tysabri and fund clinical trials for point-of-care testing to optimize Remicade dosing in patients, which would require FDA 510(k) approval.

 

 

Asked about his short-term plans, the entrepreneur said he hopes to get market validation for their commercial products.

 

 

"We have gotten the feedback from pharma and payers that they see the value that we can bring," Messmer told Medtech Insight. Abreos has joined forces with unnamed pharmaceutical companies to use its tests in pre-clinical and clinical testing to optimize drug dosing.

 

 

The long-term vision calls for Abreos' tests to become the "gold standard for dose monitoring of biologic drugs."

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