Eyal Kochavi, Founder and CEO

Closely-held Vessi Medical wants to change the standard of care for superficial bladder cancer by using a surface cryotherapy approach in a minimally invasive in-office treatment alternative to surgery.

“We have successful proof-of-concept data in porcine studies and are designing first-in-human trials, hopefully to begin at the end of 2019 or early 2020,” Eyal Kochavi, founder and CEO, says in an interview with BioTuesdays.

“By freezing the tumor, our technology has the potential to ablate tumors, eliminating the risk of dispersed cancer cells, without damage to bladder muscle, meaning no harm to bladder functionality,” he adds.

Vessi, which is a member of Israel’s Trendlines Group, is targeting a $1.2-billion market opportunity to treat non-muscle invasive bladder cancer (NMIBC), which invades the inside lining surface of the bladder.

Mr. Kochavi explains that Vessi’s cryo device is inserted into the bladder via a cystoscope and using standard optics, a physician identifies the treatment area and releases a cryo spray to ablate the cancerous tissue. A 15-second spray can ablate an area of 1/2-to-1 square cm.

“We believe this easy-to-use in-office system to treat NMIBC will be readily adopted by physicians who already have experience using cystoscopes,” he contends.

According to Mr. Kochavi, NMIBC is usually not life threatening, if being treated, but greatly impacts a patient’s mental health and affects their quality of life by causing sexual dysfunction, pain and blood in urine, and frequent need to urinate.

Studies have shown that of all bladder cancers - the fourth most common cancer type in men – 75% are NMIBC. Some two million people suffer from NMIBC globally, with 300,000 new cases diagnosed annually. “This suggests that people are living with the disease but enduring a reduced quality of life,” he adds. “Patients with bladder cancer also require frequent hospital readmissions, straining health care systems.”

The standard of care for NMIBC is transurethral resection of the bladder tumor, a surgical procedure that involves passing small instruments down the cystoscope to cut any tumors out of the bladder lining.

Mr. Kochavi points out that studies have shown there is an up to 80% recurrence rate of NMIBC after a transurethral resection because of missed tumors, dispersion of cancer cells and incomplete resections. “Not only does this result in repeat hospital procedures but can also lead to bleeding and perforation of the bladder, damage to muscle tissue – harm to bladder functionality - and reduced quality of life,” he suggests.

Easy-to-use, novel cryotherapy system to treat NMIBC

“Our in-office treatment represents a win-win for patients through a safer, less invasive treatment to improve quality of life,” he contends. “Physicians would benefit from an improved treatment option, patient retention and increased revenue stream, with the health care system benefiting from reduced costs.”

Surface cryotherapy is a potential “paradigm shift” in the treatment of superficial bladder cancer, Prof. Gilad Amiel, a scientific advisor for Vessi, said in a statement. Prof. Amiel is also chairman of the department of urology at Rambam Hospital in Israel and adjunct associate Prof. of urology at Baylor College in Houston.

“Histology results [in animal studies] demonstrated efficacy of tissue destruction and safety, since there was no bladder perforation or bleeding,” he added. “This gives us confidence to proceed to first-in-human trials.”

Mr. Kochavi says Vessi is seeking up to $3-million to finance its first-in-human trial, begin the regulatory submission process and start a pivotal program in 2021. The proof-of-concept study is expected to enroll about six patients and include a six-month follow-up. The company may also apply for additional non-dilutive grants from the Israeli Innovation Authority.

“We hope to seek 510(k) regulatory approval with the FDA and CE Mark in Europe in early 2022 and start commercialization later in that year,” he says, adding that U.S. reimbursement is already in place.

The company initially plans to target low-grade papillary tumors, which account for about 70% of all NMIBC cases and represent an $850-million annual worldwide market, Mr. Kochavi notes. It then would move to treat high-grade and carcinoma in-situ, a $350-million annual market.

Beyond NMIBC, Mr. Kochavi suggests Vessi’s technology could have future applications in the treatment of recurrent urinary tract infections, overactive bladder and upper urinary tract carcinoma.

*This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of Vessi Medical, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Company Highlights

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After recently conducting five first-in-man coronary stent procedures robotically in India, Corindus Vascular Robotics (NASDAQ:CVRS) plans to perform its first remote vascular cases in the U.S. in mid-2019, leading to a potential product launch in 2020.

“Our telerobotic platform represents a disruptive care model that has the potential to bring faster treatment to stroke victims in remote, underserved patient populations around the globe and enhance outcomes,” Mark Toland, president and CEO, says in an interview with BioTuesdays.

When treating stoke, time is paramount and delay in getting treatment is potentially deadly. For every minute that the brain lacks blood flow, some two million neurons are lost forever, Mr. Toland says. “The brain is not muscle; it cannot get stronger; it can only get weaker.”

According to the American Heart Association, there are some 900,000 incidents of stroke each year, resulting in more than 140,000 deaths. Stroke is the leading cause of moderate-to-severe disability as victims require special home care or must enter long-term nursing facilities. “Early treatment with remote robotics could increase the chances of recovery by up to 90%,” Mr. Toland contends.

He says vascular robotics is not distance dependent. “We’ve done procedures at three miles and at 103 miles. The issue is good connectivity between a physician and robot in the catheterization lab in hospital A and a robot and patient in hospital B.”

According to Mr. Toland, the expansion of vascular robotics would benefit hospitals by growing patient volume and satisfaction, while physicians can extend their career by reducing burnout and avoiding travel to another hospital to treat patients.

“Patients are also big winners because they can be treated locally and have a faster and more comfortable recovery,” he adds. “Yet only a fraction of patients are being treated because of a delay getting to a hospital and a limited number of specialists.”

In collaboration with Apex Heart Institute, the five-stent cases that took place in India in December 2018 were completed by a physician 20 miles away. In addition to the human cases, Corindus conducted a number of successful preclinical studies in 2018 in porcine models.

“We achieved a series of technical milestones in 2018 that demonstrated our remote technology has utility today, not 10 years from now,” he adds.

CorPath GRX

CorPath GRX, the company’s second-generation robotic platform, received FDA clearance in late 2016 for percutaneous coronary intervention (PCI), such as placing stents in the heart. In 2018, the platform received FDA clearance for peripheral vascular intervention (PVI), such as clearing plaque build-up in arteries in the legs. CorPath GRX has been used in about 2,000 PCI cases globally.

In February, Corindus filed for premarket clearance to use CorPath GRX in neurovascular intervention (NVI) for the treatment of stroke and aneurysms. If the FDA clears the application in mid-2019, Corindus would become the world’s first and only robotic platform indicated for use in PCI, PVI and NVI cases. It would also clear the way for remote coronary clinical testing in humans in the U.S. in 2019.

“An expansion of CorPath GRX to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment,” Mr. Toland contends.

He says clearance of CorPath GRX was transformational for Corindus because physicians are now in control of every device that goes into the body. CorPath GRX also enables precise micromillimeter movements in placing implantable devices, such as stents, in a patient.

In 2018, the company also received 510(k) clearance from the FDA for the first automated robotic movement in its technIQ series designed for CorPath GRX. The software feature, Rotate on Retract (RoR), represents an upgrade to existing robotic systems and marks the first step in Corindus’ path to procedure automation.

“We believe artificial intelligence through procedural automation will increase the value of robotics in the catheterization lab by reducing variability of treatment and procedure time, and improving the overall quality of patient care,” Mr. Toland says.

The company also began international expansion of CorPath GRX in Europe, Japan, India and Australia in 2018.

Mr. Toland says the market opportunity for vascular robotics is substantial. There are more than three million PCI treatments worldwide a year, of which 60% are in the U.S., Japan and India. Corindus’ target market in PCI is critical limb ischemia below the knee, which represents 11% of the overall two million-plus PVI procedures performed around the globe.

And of the 900,000 incidence of stroke in the U.S. a year, Corindus is focused on the treatment of large vessel occlusions, which currently represents approximately 35,000 cases in the NVI market.

“We believe we can expand the total addressable stroke market with remote access. So, our ability to grow the market is significant and continues out over time,” he suggests.

Last week, the company reported revenue of $4.7-million for the fourth quarter of 2018 and $10.8-million for all of 2018, both 12% year-over-year increases. Sales of consumable cassettes reached 522 for the fourth quarter, an increase of 15% from the same period in 2017.

Corindus recently demonstrated its vascular robotics platform at meetings of the Transcatheter Cardiovascular Therapeutics and The Amputation Prevention Symposium.

“Across all vascular markets, we are seen growing influence of robotics in clinical practice,” Mr. Toland says. “Robotics integrates into high tech care models and we see a future where devices, imaging and navigation in the body are controlled remotely with artificial intelligence.”

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Bob Terbrueggen, Founder and CEO

Closely-held DxTerity has developed the first affordable diagnostics platform for at-home monitoring of autoimmune disease activity and response to drug treatment, with tests that use longitudinal gene expression data obtained from biological samples taken from the same subject at different time points.

“We are the only self-collected, blood-based sample system for low-cost longitudinal RNA profiling designed to improve patient care,” Bob Terbrueggen, founder and CEO, says in an interview with BioTuesdays.

“We are bringing the power of precision medicine to autoimmune disease with our Autoimmune Profiler (AIP), a multi-module assay that monitors RNA expression of key immune pathways, using a self-collected blood sample shipped to us by U.S. mail,” he adds.

Dr. Terbrueggen explains that the chronic nature of immune-mediated diseases, such as multiple sclerosis (MS), lupus and rheumatoid arthritis, requires a lifetime of care. And the complex nature of these diseases makes management difficult.

“Simple, low cost and comprehensive monitoring tools are needed to improve patient outcomes and reduce costs associated with long-term disease management,” he contends. “Real-world data and frequent longitudinal monitoring can help provide a more complete picture of disease activity and are key to managing disease for individual patients, especially with the emergence of new and costly biologic drugs.”

And time is crucial with many autoimmune diseases, Dr. Terbrueggen contends, adding that physicians need to help patients achieve remission in a timely manner to avoid long-term organ damage.

DxTerity’s technology platform is a three-step process that begins with DxCollect, a patented at-home collection kit designed to obtain a few drops of blood using a finger stick. The kit, which includes 14-day blood stabilization technology, is then mailed to the company’s lab.

DxTerity’s technology platform is a three-step process

The company’s DxDirect platform performs genetic testing of the RNA in the blood sample. Dr. Terbrueggen says each blood sample is treated with chemical ligation dependent probe amplification and polymerase chain reaction amplification, resulting in genes that are a unique size. The genetic material is then fed into a ThermoFisher 3500Dx series genetic analyzer to achieve high throughput readout.

DxTerity also offers DxReach, a clinical study platform that enables nationwide digital recruitment of study participants utilizing the same from-home technology. DxReach also has the potential to improve doctor-patient disease management.

Dr. Terbrueggen says that among other things, DxTerity differentiates itself from the competition by DxCollect’s longer stability of a blood sample as well as requiring patients to collect only a few drops of blood.

“While we sample only about 50 genes, our daily sample throughput is in the thousands and we have developed a test costing about $100 for lupus and MS, compared with competing tests costing $1,000-to-$1,500.”

An estimated one million people in the U.S. suffer from MS and systemic lupus erythematous (SLE), the most common form of lupus, making “affordable home diagnostics a critical unmet need,” he adds. DxTerity figures there is a $300-million near-term opportunity in SLE and MS, evolving to $1-billion over time.

SLE is a debilitating autoimmune disease that attacks multiple organ systems in the body. Only one FDA therapy – GlaxoSmithKline’s Benlysta – has been approved for SLE in the past 60 years. The symptoms of SLE vary widely between people, making “patient stratification via precision medicine critical to future SLE disease management,” Dr. Terbrueggen contends.

At the 2018 American College of Rheumatology annual meeting in October, DxTerity presented data from its LIFT study where 1,400 participants with SLE self-collected three blood samples during a two-month period. The study demonstrated an analytic success rate of 97%, with 92% of participants reporting a good-to-very-good experience.

“The AIP test in the study provided high precision, gene expression analysis of 12 immune-related disease pathways, including Type 1 interferon (IFN) levels,” Dr. Terbrueggen points out.

In addition, high IFN levels measured in LIFT correlated with scientific literature of SLE severity, indicating that IFN levels were higher in African Americans and Asians, compared with Caucasians; and higher in those participants diagnosed at less than 18 years of age, compared with disease diagnosis between the ages of 18-and-30 and diagnosis over the age of 30.

“From-home access to patients with autoimmune disease opens up opportunities for remote care and regular disease monitoring at the biological level,” Dr. Terbrueggen suggests.

DxTerity had 2018 revenue of $10-million from clinical testing by its pharmaceutical partners and key opinion leaders, and a long-term government biodefense contract valued at $150-million plus.

In the first quarter of 2019, DxTerity plans to officially launch its modular immune profiling (MIP) laboratory developed test in its CLIA/CAP testing lab. Dr. Terbrueggen says MIP is an expanded version of AIP with broader applicability, expanding beyond autoimmune disease, where more than 300 drugs are now in the pipeline; but also in transplant, immuno-oncology, asthma and chronic obstructive pulmonary disease, where more than 600 drugs are in clinical development.

The company also has three programs being filed with the FDA in the second half of 2019, including the AIP test; a REDI-Dx radiation test, which is being funded by the federal government; and a premarket approval review for DxTerity DLBCL, a diffuse large B-cell lymphoma cell-of-origin test.

Dr. Terbrueggen says managing autoimmune diseases today requires patients to visit a physician for testing with tools that are often ineffective, inconvenient, and/or cost-prohibitive.

“DxTerity’s solution offers consistent, low-cost monitoring with at-home patient kits, improving on current methods of disease monitoring by empowering patients to improve their health proactively through real time data analytics, enhancing physician-patient communication with clearer results and improving health outcomes.”

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Gregory Montalbano, Principal

As a principal of closely-held MIDI Medical Product Development, Greg Montalbano has a unique background in industrial design, usability/ergonomics and manufacturing with over 25 years of experience developing products for medical, life sciences and home healthcare markets. With his co-owner brother, Chris, they pioneered the firm’s integration of a multi-faceted design process, known as DevelopmentDNA, which addresses all stages of product design from market insight and research through innovation, engineering and production. Committed to generating success for MIDI’s medical and life sciences clients, Greg and Chris Montalbano are focused on securing strategic product results that answer clients’ needs. In this interview with BioTuesdays.com, Greg Montalbano discusses the company’s approach as a medical product development-consulting firm.

Let’s begin with a brief history of MIDI.

The company was started by our father, Anthony, in 1972 and has always been focused on medical and scientific product development. As a teenager, my father had an aptitude test and was told he was best suited to be an industrial designer. On the GI Bill after the war, he studied industrial design at college and started the company in the basement of our apartment building in Flushing, NY. Chris and I took over the business in 1994. Chris has a background in mechanical engineering and, with my background in industrial design, we have a good partnership that utilizes different sides of the brain, as it were. Having two different mindsets is especially useful when it comes to creating differentiated products for clients and capturing marketplace opportunities.

How big is MIDI?

We have a staff of 30 people plus an innovation center in Smithtown, NY. We employ mechanical and electrical engineers, market researchers, “voice of the customer” experts, industrial and software designers and interface experts that translate all the research inputs into user-driven designs. We operate as an innovation swat team to pull all these disciplines together and cross-pollinate them to generate forward thinking innovation in and around our clients’ technologies.

Can you run through your core competencies?

Our expertise covers global research; technology and IP development; usability-centered product development; industrial design and innovation breakthroughs; engineering and total systems development; ergonomics, which is the science of fitting products to people; electrical and mechanical engineering; software development and application tools; user interface and user experience mapping; thus optimizing clients’ time, money and reliability.

Can you explain DevelopmentDNA?

As a consulting firm, we need to take a quick and deep dive into a client’s technology and applications. As we develop this understanding, we want to quantify and qualify our innovation relative to a client’s needs and their marketplace. DevelopmentDNA is our proprietary design process, which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. It provides innovative design, reliable engineering, design controls procedures for regulatory approval, manufacturing production solutions and product branding. DevelopmentDNA allows MIDI to respond with intelligent, informed, targeted development program directives emanating from top-level strategies, ensuring predictable success for our clients.

At what stage of product development do you typically become involved?

We can help clients with getting early technology off the ground; we can work with more robust device prototypes where a client is looking to move their product towards commercialization; and we can help redesign existing products to make them more competitive in the marketplace. So, to turn product 1.0 into product 2.0, we have teams that can work with different disciplines, like manufacturing cost optimization, regulatory, IP, design, usability and competitive differentiation. We work with different companies in a multitude of industries, with varying technologies utilizing a variety of manufacturing processes.

How do you handle a client’s IP?

If a startup is interested, we can do equity partnerships with convertible notes or a straight up consulting services contract, where the IP would stay with the client, or we can blend an equity investment with consulting services. The best technical partnerships are the ones that move a program forward.

What kind of competition exists in your sector?

While we have relationships with manufacturers, we don’t manufacture a client’s products. We compete with contract manufacturers who like to capture the front-end design and development work and then segue back to do the manufacturing. We also compete with a company’s in-house design and development work and compete with other consulting firms. Although when it comes to medical product design and development, very few consulting firms have our ability to be compliant with ISO-13485, FDA Quality System Regulations and FDA 510(k) guidelines for approval to sell a Class 1, 2 or 3 medical device in the U.S.

What kind of products has MIDI designed and developed?

In our 40-plus years of business, we have commercialized a multitude of advanced medical technology, devices for various client types from start-up and emerging companies to GE Healthcare. We have designed and developed wearables and handhelds, such as a smart injector that monitors and updates dosages through a cellular network and aids in compliance; tabletop surgical and diagnostic equipment; disposables, like a “lab on a chip”; floor standing devices like a modular dental workbench; and large format products, like digital and vascular imaging systems.

Can you describe one of these in more detail?

A good example is FlooRX by Harbor Innovations, which is preparing to go into production this year. The FlooRX concept was inspired by Harbor, a startup on Long Island, to tackle the dangers of hospital-acquired infections, like the hard-to-kill, Clostridium difficile (C. diff). The owner of Harbor also owns multiple assisted-living facilities for the elderly and knows how these pathogens can be transported on footwear. Harbor’s initial invention had UV light bulbs inside a casing that looked like a bathroom scale and did kill C. diff.

So, we partnered with Harbor and, utilizing our DevelopmentDNA processes, developed FlooRX as a next-generation, internet-enabled (IoT), compliance tracking, wafer-thin device, embedded in the floor, with UV-C LED light-emitting diodes, capable of killing C. diff and a host of other pathogens, including E. coli, MRSA and Candida auris, a fungal infection. Digitally controlled UV-C LED that can kill C. diff have been commercially available for only a few years, so we were on the leading edge of this new application.

In terms of its usability, the goal is to install FlooRX outside of the OR so that surgeons and nurses would stand on it for 10 seconds to sanitize their footwear/booties; in critical-care centers that house people with compromised immune systems; and in assisted-living centers. FlooRX also is internet-enabled so that hospitals can track who stepped on the device and for how long in order to collect data and undertake corrective measures, if necessary.

As an equity partner, we hosted around 25 investor meetings to help Harbor get off the ground. Harbor is developing a sales team to market FlooRX and as an equity partner, we will remain involved for any design modifications or backend software requirements to incorporate FlooRX with a client’s software systems.

FLOORX is a footwear sanitizing station that uses the latest in UV-C LED technology to destroy over 94% of microbes in just 10 seconds.

How do you see the future of medical device development?

The way I see it, the best way to look at the future, is to invent it. We believe the growth of personalized medical devices and cost-effective home applications will dominate the sector. Personalized medical products will be tailored to an individual’s genetic makeup and lifestyle needs, and be more preventative than corrective, and driven by cloud databases and telemedicine. In the next decade, we see tremendous growth of hand held and wearable medical devices. This transition to personalized medicine will be less about going to a physician for a course of costly lab interventions and more about decisions brought to you by new technologies that you can purchase at a pharmacy and manage at home. And the devices needed going forward will be the ones we design.

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