MedTech Strategist working together with The Medical Alley Association for the very first time brought their premier innovation summit to Minnesota, a place now considered by many to be the global epicenter of health innovation and care. Over the two-day long event more than 35 start-up and emerging medical companies presented their technologies and devices to representatives of leading venture capitalist and investment banks, and also to large medical device companies.
Considering that funding is of major importance to the field of medical innovation, this event gave both investors and entrepreneurs a chance to explore funding and investment opportunities in addition to ways of structuring partnerships.
Kicking off the summit was Dr. William Cohn, a prominent figure in medical innovation. Dr. Cohn delivered a very inspiring presentation on how to foster a culture of medical device innovation. He talked about his journey as an innovator and shared some of the lessons he learned through his twenty plus year career in medical innovation. Dr. Cohn ended his talk by sharing some pictures of what would be the Center for Device Innovation by J&J in Houston, Texas. The facility is more than 25,000 square feet of workspace equipped with state of the art machinery and tools for innovators to use. Dr. Cohn, who was named as the director of the Center of Device Innovation, described it as “a dream environment to innovate.” The center is expected to open its doors this November.
Following Dr.Cohn’s motivational speech, which managed to charge the attendees and put them in the right mindset, each of the start-up companies was given ten minutes to take on the stage and to try to persuade investors to join their quest. There were many promising start-ups who participated in the summit, but we will list only some of the companies that we found to be particularly interesting.
Mardil Medical’s flagship product is the VenTouch system, a unique, category re-defining approach to treating functional mitral regurgitation by simultaneously treating the distorted ventricle and the dilated (but otherwise healthy) valve. It’s not a replacement for a diseased valve, as is the case with many new innovations in mitral replacement and repair. VenTouch instead is a pressure pouch that is implanted around the dilated, dysfunctional ventricle and that uses inflatable chambers to correct anatomical positions of the displaced papillary muscles to return the valve leaflets to a normalized position. During this event, Jim Buck, President and CEO of Mardil Medical, presented their second generation of VenTouch to which the company added a second inflatable chamber to directly address the ventricular displacement of the papillary muscle, the root cause mechanism in functional mitral regurgitation.
Peytant Solutions (Plymouth, Minnesota) presented the first ever stent that is fully covered with amnion. Studies have shown that all stents implanted in the body are interpreted as foreign by the immune system, with a certain degree of body reaction and rejection. This might lead to complications, such as infection, restenosis, thrombosis, etc. It is established that amnion, a natural and renewable component, plays a role in protecting the fetus from being recognized as a foreign body and rejected by the mother’s immune system. Amnion is also known to have anti-inflammatory and anti-scarring capabilities. So, by covering a stent with amnion, Peytant Solutions hopes to tackle the issue of foreign body reaction. Peytant Solutions’ first stent, AMStent, is a tracheobronchial stent for palliative care.
Patrona Medical (Greenville, South Carolina) showed off their product, Foley Garde, a new Foley catheter that can detect urinary tract infections as soon as possible. Foley Garde catheter is equipped with a disposable sensor, which is designed to change color if nitrite and leukocytes (infection markers) are detected in the urine. Subsequently, a sensor will pick up the color changes and transmit an electronic message to the medical staff to alert them of the infection. This would give the medical team a chance to intervene and remove the catheter before further complications occur. Foley Garde has both a standard mode and wireless mode, and the system is also able to monitor patients’ urinary flow, electronically measure urinary output, and prevent retrograde contamination.
“Given the fact that catheter associated urinary tract infections are some of the most common hospital acquired infections in the United States… Foley Garde, could have a huge impact on healthcare” said James Conner, CEO of Patrona Medical. The company will start their first in-human study in March of 2018.
Impleo Medical (Saint Paul, Minnesota) presented an innovative way to treat Gastroesophageal Reflux Disease (GERD), a condition that affects one in four adult Americans (nearly 65 million people in the US alone). “ The first line of treatment for GERD usually includes heartburn drugs called Proton Pump Inhibitors (PPIs). Studies have shown that chronic use of PPIs could increase the risk of heart attack, dementia, chronic kidney disease, and early death, and many patients still have symptoms despite PPIs.” said Juliana Elstad, President and CEO of Impleo Medical. Impleo Medical’s technology uses an injectable material composed of tiny carbon beads in a gel. This material is nonreactive and cannot be absorbed. It’s injected into the lower esophagus in a one-time procedure during GI endoscopy with no hospital stay. It creates a barrier for stomach acid to flow back into the esophagus. Impleo Medical is starting a NECTAR trial conducted by gastroenterologists in multiple centers in the U.S., upon completion of which the company plans to submit for FDA approval.
Cerevasc (Boston, Massachusetts) touted their product called eShunt, a new treatment option for communicating hydrocephalus. The traditional treatment for communicating hydrocephalus is a burdensome and invasive surgery called ventriculo-peritoneal shunt (VPS) placement. To complete this procedure, the surgeon performs a craniotomy to access the brain ventricles and connect it via a tube to the peritoneal cavity. Nearly 50% of these devices will fail within two years of implanting due to infection, device failure, etc.
eShunt uses a completely different approach that mimics the natural system in a healthy individual, where cerebrospinal fluid (CSF) is reabsorbed into the venous system. eShunt is a one way valve implanted in the subarachnoid space to regulate CSF flow from the ventricles to the venous system. This valve is implanted by a minimally invasive procedure using a catheter inserted via the percutaneous femoral venous approach under X-ray guidance to reach the inferior petrosal sinus (IPS). “We believe our eShunt system represents a truly disruptive approach in the standard of care for treating communicating hydrocephalus,” said Aaron Levangie, General Manager of Cerevasc. The company is currently working on launching studies to submit for FDA approval.
Isomark (Madison, Wisconsin) presented their technology, also called the Canary, which looks at specific markers in exhaled breath to detect infections. Joe Kremer, CEO of Isomark noted, “We are working to make breath the next vital sign”. Isomark is a non-invasive test where a patient simply blows into a disposable bag. This bag is then plugged into a device that is able to measure the ratio of carbon isotopes in exhaled breath and detect any infection presymptomatically. It also monitors a patient’s response to treatment, and tracks the progression of an infection. Isomark wants to give health workers a tool to treat their patients early, while avoiding antibiotic overprescribing, which could create antibiotic resistant organisms. The company will be launching their regulatory studies later this fall, and it is expected that it will take up to eight months to complete.
Woven Orthopedic Technologies (Manchester, Connecticut) showed off OGmend, the first technology specifically designed to help surgeons achieve screw fixation when operating in patients with compromised bone by focusing on the screw-to-bone interface. Woven’s OGmend device is made of Dacron and is inserted into the bone before driving an ordinary screw during internal fixation. This technology is designed specifically for fracture repair surgeries in compromised bone, such as bones in the elderly. OGmend works similarly to anchors used by carpenters when placing screws in a wall to prevent them from loosening and/or falling out. If screws loosen or fall out in patients, this could mean going back to the operating room for a revision procedure. OGmend works by increasing the surface area of contact between the bone and screw, and distributing load transfer, among other things. It also prevents the loss of screw engagement over time by creating an environment conducive to bone healing and remodeling. Woven’s OGmend is already in use in New Zealand and Australia. The company filed for FDA approval last year and is hoping to get it by the end of the year.
FemPulse (Mahtomedi, Minnesota) presented FemPulse, a vaginal ring that utilizes neuromodulation to treat overactive bladder (OAB). The American Urological Association (AUA) OAB guideline literature review concludes that OAB prevalence ranges from between 9% to 43% in women. In short, OAB affects over 15 million women in the US and about 300 million women worldwide.
The available treatment options range from medications, with limited efficacy and various side effects, to more effective yet invasive treatment options, such as sacral implants. These involve electrical leads implanted through a naturally occurring hole in the lower spine over a nerve root that influences bladder control. FemPulse technology provides a self-retained neuromodulation device that is vaginally inserted, and fits around a woman’s cervix to directly stimulate the nerves that control the sensation and function of the bladder. “Fempulse is accessible, affordable, discrete, and easy to use”, concludes Don Deyo, CEO of Fempulse “The goal is to provide women with OAB a treatment option that has the benefits of continuous neuromodulation while avoiding surgery and implants.”
Oculogica (New York, New York), a neurodiagnostic company, discussed EyeBOX, a noninvasive, objective diagnostic test for TBI and concussion. “Concussion is one of the greatest challenges of our lives. It is the number one cause of death and disability under the age of 35” Said Rosina Samadani, CEO of Oculogica. “When you walk into the ER and you have had a heart attack or chest pain, you get five quantitative tests…. If you walk in with a head injury, you get one test that hasn’t changed in three decades. It is called ‘follow my finger’. We at Oculogica think we can do better”.
EyeBOX plays a four-minute film clip in front of the patient while tracking eye movements to measure how well the cranial nerves are functioning. There is no baseline test, so the test can’t be gamed. EyeBOX is also able to detect elevated intracranial pressure, which could result in sudden death.
The Medical Alley Innovation Summit included a number of panel discussions on today’s startup climate, provided attendees with a unique perspective on funding options for medical innovation, and gave recommendations for how to push the industry forward. Participants also enjoyed ample networking opportunities, and the conference organizers received an abundance of positive feedback. Consequently, MedTech Strategist and the Medical Alley Association decided to add Minnesota to their list of annual stops. They will later release the date for the next Summit, but it will most likely take place next fall.
