startup

Medical Device Startup LifeSAVR Solutions is Developing a New Guidewire to Improve Aortic Valve Repair

Jordan Pollack saw a problem.  While he, and his three other LifeSAVR Solution Founders, were in graduate school at the University of Michigan, they observed a transcatheter aortic valve replacement (TAVR) surgery at Beaumount Hospital in Royal Oak, Michigan.  This minimally invasive procedure uses a catheter and guidewire to replace diseased aortic valves in the heart.  But the only way to visualize this internal procedure, and ensure correct placement of the new valve, was through fluoroscopic guidance, or fluoro.  Using fluoro, the whole procedure is visualized in real time by X-rays projected on a screen above the patient.  Fluoro and physician experience are the only way to know that the replacement valve is in the right location before it’s deployed.  Jordan and his other classmates felt there had to be some better way to ensure proper valve placement during TAVRs that didn’t rely solely on just a 2D image and a good bit of guessing.

Aortic valve disease, or aortic stenosis, is a large problem in the US and is especially prevalent in the elderly.  One study estimated that every one in eight people over the age of seventy-five in has moderate to severe aortic stenosis[1]. 

 Aortic stenosis involves a narrowing of the aortic valve from calcification or plaque buildup.  There are a total of four valves in the heart: the tricuspid, pulmonary, mitral, and aortic valves.  These valves open in only one direction to allow unilateral blood flow through the heart.  The aortic valve connects the left ventricle to the aorta, the largest artery in the body, to funnel blood from the heart out into the vasculature.  If the aortic valve is narrowed, the left ventricle has to work harder to pump blood, which leads to improper blood perfusion to the body, weakening the heart tissue and leading to a high morbidity rate if left untreated.

Replacement of the aortic valve via open heart surgery is the gold standard for aortic stenosis treatment.  During this process, patients are opened up, the old, diseased aortic valve is excised, a new valve is sutured into place, and the patient is closed back up.  These replacement valves implanted during surgery are usually metal based and inserted during a procedure that lasts for several hours.  Afterwards, patients usually have a two-week hospital stay, followed by several weeks of recovery.

 However, there’s another option on the market, at least for high risk US patients.  “One of the biggest technologies and treatment modalities that came storming out of the market is TAVR, which is transcatheter aortic valve replacement,” explains Jordan.

TAVR first hit the market in Europe in 2006-2007 and entered the US commercially in 2011.  TAVR was given FDA approval in the US only for high risk patients with aortic stenosis, those for which surgery would be too risky to complete. 

Approximately 300 to 500K elderly US patients are eligible for this minimally invasive procedure.  As opposed to open heart surgery, TAVR is a catheter lab procedure that takes ninety minutes or less to complete.  During the procedure, a three-meter guidewire is traced up an artery, usually the femoral artery in the leg, with fluoro guidance.  The guidewire runs all the way up the artery to the aorta, through the diseased valve, and into the left ventricle.  The operating physician then uses a balloon to expand the damaged, narrowed valve.  The balloon is removed and the new, prosthetic valve is traced along the guidewire path with a catheter, until it reaches the diseased valve.  Most current valves used in TAVR are self-expanding and made up of valve leaflets from pig or cow pericardium, as opposed to the metallic valves used in open heart surgery.

TAVR has been successful and there are promising results from clinical trials in high risk patients.  “The push is to make TAVR the goal standard to completely replace open heart surgery,” explains Jordan.

There are some potential issues with TAVR that have slowed down the process for the procedure to become the standard of care for aortic stenosis treatment.  “The big thing is longevity.  No one really knows how long these valves [used in TAVR] will last,” says Jordan.  The field is just beginning to see the first patients who have had TAVR replaced valves for ten years. 

The other problem compared to open heart surgery is the general…murkiness of the whole process.  Physicians aren’t opening up a person like in open heart surgery and are relying on fluoro and 2D images to determine if a valve is in place before it’s deployed- a process that leads to 3-5% of TAVR valves being acutely misplaced, which can lead to perivalvular leak.

Valves can also be chronically misplaced, where they are just slightly misaligned or shift overtime from excessive calcification.  Besides health implications to the patient, misplaced valves are pricey.  Each valve costs $40K to replace, which has to be assumed by the hospital system in cases of valve misplacement by the physician.

“That’s really the problem that we’re trying to solve, is valve misplacement during the TAVR procedure,” explains Jordan.

Jordan and his three-person team of University of Michigan graduates founded LifeSAVR Solutions and are developing a product called the Corfinder; “cor” is the Latin word for heart.  Their product will provide “quantitative, adjunctive confidence for physicians to know that he or she has place the valve properly.”  The Corfinder is not meant to replace fluoroscopic guidance or physician experience, but to complement them.  The team is creating this specialized guidewire, the Corfinder, with a series of sensors along the distal tip.  The Corfinder will help to refine detection of the native valve during TAVR procedures and ensure better alignment between the annulus, or base, of the new prosthetic valve and old, diseased valve.   

The LifeSAVR Solutions team is currently in the technology and feasibility stage of the process.  They are incorporating the tiny sensors onto the guidewire and are getting the product down to a functional form factor.  

Jordan has found some great resources in the Twin Cities to help the team with this process.  In CoCreateX, he found a group where he could interact with people doing similar types of things.  However, “…the biggest community that’s provided me with connections is the Jewish community,” he notes. 

 


[1] http://www.edwards.com/eu/procedures/aorticstenosis/Pages/prevalence.aspx

Mayo Clinic Business Accelerator Startup grandPad Takes Strides in Senior Market

The mantra that drives Scott Lein, CEO and Co-Founder of GrandPad, to build intuitive, transparent, and engaging technology that enables seniors to enjoy life to the fullest.

The GrandPad tablet fills a key technological void: a mobile device that is not only user friendly for seniors, but truly connects seniors with their loved ones. Every aspect in the design of GrandPad has been tailored to suit the senior demographic, assuming absolutely zero prior computer experience, so much so that GrandPad stands by their “90/90” rule: A 90-year-old can fall in love with GrandPad within 90 seconds of opening the box. 90 seconds: the approximate length of time it takes to turn on and get through step two of an iPad set-up process.

How can a 90-year-old fall in love with GrandPad within 90 seconds of opening the box?

First, the device arrives pre-charged and instantly turns on; there is no “on” button. This alone prevents any negative first impressions with suspicions of complicated technology. Second, the tablet arrives pre-configured and set-up with ultra-fast Verizon 4G LTE connectivity. Absolutely no “set-up” for the GrandPad is required. Thus, during the 90 second trial window, rather than configuring Wi-Fi networks, setting up Apple IDs, etc., the senior is experiencing the feel of the device – a 7” tablet, in a non-slip case- and, using a special stylus designed for seniors, is interacting with the device by moving through the various easily seen applications.

GrandPad easily allows seniors to:

1)   place phone and video calls

2)   receive and send email via voice recognition

3)   view family photos and videos

4)   take and send pictures using the built-in camera

5)   see the current weather for each family member’s location

6)   play a variety of games

7)   listen to music

8)   “lookup” anything via Wikipedia

9)   and call an Uber.

The result? They fall in love. The countless pictures uploaded to Facebook and Instagram throughout the family get automatically pushed to GrandPad, making sure Grandma and Grandpa are constantly in the loop. They can place a hassle-free video call and easily stay involved and connected to their family. Finally, Grandma and Grandpa have a device that keeps them simply connected to their family.

The GrandPad Journey

After Scott first introduced his 80-year-old mother to Skype, the video calls were an instant hit and quickly became a regular part of their weekly routine. However, over time the calls that had brought so much joy to both Scott and his mother crept further and further apart. Something was always wrong. Skype needed to be updated. The network modem needed to be restarted. The PC froze. An unrelated application went awry and demanded precedence.

These “normal” issues are solved with secondhand precision by tech savvy “youngsters”, but present a very real roadblock for less computer literate seniors. Indeed, these challenges left Scott’s mother constantly confused and eroded her self-confidence. Skype video calls went from bringing joy to being psychologically and physiologically harmful.

The problem was clear: technology is built for people 20 years of age, not 90 years of age. Nevertheless, conventional wisdom says that seniors just need to be trained, they need to be pushed, and they need to try harder. After all, seniors are very smart people, there’s no reason they can’t adapt. Unfortunately, this just isn’t true. When Scott realized there was no technological solution for seniors, GrandPad was born.

Solving this technological problem wasn’t exactly straightforward, but began without preconceived notions regarding what the solution should be. Instead, Scott and his son- Issac Lein, GrandPad Product Designer and Co-Founder- approached the process very scientifically and allowed the solution to reflect the problem.

For example, after quickly realizing a tablet was the best form factor, what was the right size? Many iterations later, the 7-8” size was ultimately chosen as providing the best balance between weight, screen real-estate, and portability. Prototypes were built, tested, and the results were carefully recorded. These results, in turn, influenced the resulting prototype, and the “build, test, learn” cycle continued. In what must have been a dizzying initial 6 months, over 1,000 iterations of prototypes and software were cycled through.

Minnesota Connection

Scott grew up on a farm in Decorah, Iowa- a small town about 1-hour south of Rochester, Minnesota. Scott attended Luther College in Decorah, Iowa where he double majored in computer science and business. After college, Scott worked in the Minneapolis-St. Paul area for nearly 22 years where he held an executive position with BestBuy for over 7 years, as well as positions with Target and Accenture. His relocation to Silicon Valley occurred roughly 6 years ago following a 3-year stint living in Charlotte, North Carolina.

Today, Scott splits his time between Orange County and Wabasha, where he owns a home. Despite Scott’s part-time Midwest residency, there’s clearly good reason to consider himself a “mid-west guy.”

Although GrandPad originally grew out of the Mayo Clinic Business Accelerator (and remains a current tenant), the organization is split, roughly 50/50, between Orange County and Minneapolis. The Orange County division houses the technological aspects, whereas the Minneapolis division houses the operational aspects of the company. Although separated by ~1900 miles, this company division seems to make a lot of sense. Technological innovation is the heartbeat of Silicon Valley and first class customer care is instinctive for Minnesotans.

The Future

Currently there are approximately 20 million seniors in the US and this population is expected to increase more than two fold, to ~70 million, by 2030. Accordingly, it doesn’t take a mathematician to understand the market for GrandPad users will follow a similar trajectory. Expanding globally, this market cap increases roughly 10 fold and therefore, on solely the basis of potential customers, the future for GrandPad is very bright.

Very few companies are targeting the senior demographic, leaving this particular market relatively untapped. Although Scott Lein and GrandPad are shaping up to be leaders in the tablet market, it remains unknown whether or not other technology platforms targeted at seniors will also gain a foothold.

Advice

For aspiring technology entrepreneurs, Scott offers two pieces of advice. First, identify your goal and focus everything you do around that very specific goal. Critical to success is doing one thing well – “don’t be an inch deep and a mile wide”. Startups lack two precious resources: time and money. Accordingly, do not be afraid to say no to anything that does not directly support your mission. Second, put the customer first, resolving any issues that arise ASAP. Technological innovation should be customer driven, and this simple, yet fundamental point, should be imprinted into the DNA of your company and employees.

Bioagriculture Startup MNPHARM Develops Plant-Based Individualized Cancer Treatment

Imagine seeing an individualized medicine treatment grow right before your eyes.  Dave Roeser and MNPHARM want to make that happen.  Using indoor agriculture technology developed in sister company Garden Fresh Farms, MNPHARM harnesses the power of plants to produce personalized immunotherapy treatments.  The emerging company uses genetically modified tobacco plants to generate plantibodies- or plant-based drugs- and is well positioned to make strides in the rapidly developing plant biologics market.

Vaccines are powerful public health tools that protect the body from infection, prevent the spread of disease, and train the immune system to home in and destroy antigens.  White blood cells play a major role in the immune response.  Specialized white blood cells called lymphocytes are the main cell types responsible for acquired immunity, where the body recognizes and “remembers” foreign antigens- proteins present on the cell surface that can elicit an immune response.  After exposure to certain antigens, B lymphocytes produce and secrete specialized proteins called antibodies.  These antibodies can bind to the antigens, leading to eventual cell destruction.

Antigens help the body recognize its own cells from infectious microbes or damaged and diseased cells.  After exposure to “non-self” antigens on foreign microbes, the immune system develops memory toward these infectious particles, quickly shutting down potential infection if the microbe should re-enter the body.  Most vaccines are composed of weakened or dead microbes, which introduce these “non-self” antigens to the immune system, allowing B lymphocytes to mass produce antibodies specific to those infectious microbes and protect the body against future infections. 

Conventional vaccines are produced from chicken eggs; a typical vaccine manufacturing company burns through about $600,000 of chicken eggs in a single day.  This type of vaccine development takes about six months, a slow process that allows little flexibility to pivot production if the infectious viral strain mutates and hampers the ability to address key public health issues in a timely manner.

MNPHARM uses a disruptive approach to generate plantibodies, or plant-based vaccines.  Instead of chicken eggs, MNPHARM uses tobacco plants as vaccine-production factories.  MNPHARM’s plantibody approach leads to a much faster, cheaper, and safer vaccine production than conventional methods.  This method uses no animal products, eliminating the risk of microbial contamination in the final product.  Most important, the plantibody vaccines are generated in only six days, not six months.

MNPHARM’s plantibodies are produced in small batches by design, making them perfect to treat rare diseases.  Plantibodies may play a vital role in the individualized medicine space and MNPHARM is well positioned to break into the cancer vaccine market with this technology.

Immunotherapy- medicinal treatments that boost the power of the immune system- is a very active area of cancer research.  Unlike preventative vaccines which stop a disease from ever appearing, therapeutic vaccines attack a disease while it’s occurring.  Cancer therapeutic vaccines can target and destroy tumor cells and even prevent cancer recurrence.  These vaccines can stimulate the body’s immune system to detect, home in, and extinguish cancer cells already present in the patient.

Cancer cells by definition are foreign substances that are recognized by the immune system through a couple different mechanisms.  These cells can present higher levels of “self” antigens than healthy cells, have antigens on their cell surface which are not normally found in that specific tissue, and can present novel antigens from gene mutations.

Dave Roeser and colleagues developed innovative, disruptive technology to grow plants indoors in a cheaper, resource-efficient manner at Garden Fresh Farms.  But they always dreamed of using the technology for cancer treatment.  MNPHARM uses the same rotating garden technology already proven in Garden Fresh Farms to grow their tobacco plants and produce plant-based medicine in Minnesota all year long.     

The whole process starts with bacteria and a little bit of molecular cloning.  With MNPHARM technology, a tumor sample is taken from a cancer patient and processed using the MNPHARM biopsy kit.  DNA specific to the cancer cell is isolated, which codes for cancer-specific antigens.  The DNA is spliced into a cloning vector- a piece of circular double-stranded DNA that does not insert into the bacterial genome and synthesizes its DNA independently from the bacterium’s own genetic material.  The tobacco plants are infiltrated with the bacteria and the plant synthesizes the cancer antigen from the vector-containing DNA.  After just six days, the tobacco leaves are ground up and the antigens extracted and purified to get the final plantibody product.  This individualized plantibody can be used to treat patients and hopefully elicit a strong enough immune response to kill the cancer cells presenting that specific antigen.

MNPHARM is currently in collaboration with Mayo Clinic to further develop these plant-based individualized medicinal treatments.  How amazing would it be to walk through the Mayo buildings and see 8x4 foot rotating drums of tobacco plants, synthesizing your own personalized medicine?  In less than one week a patient could visit the clinic, have a biopsy taken, and receive specialized treatment, a process not possible without this disruptive technology. 

Business is on the upward trajectory for MNPHARM.  The company competed proof of concept of their technology in December 2015.  They are scaling up a vaccine-production facility in Maplewood and hope to eventually set up shop in Rochester.

Garden Fresh Farms uses Indoor Aquaponic System to Sustainably Farm in Minnesota all Year Long

Maplewood-based Garden Fresh Farms provides a disruptive solution to conventional farming.  Their unique system allows for sustainable, year-long, indoor farming, providing 24-hour fresh food to consumers regardless of location.

I had to opportunity to learn about Garden Fresh Farms and spin off company MNPHARM from Founder Dave Roeser at the Worthington Bio Science Conference a few weeks ago.  Garden Fresh Farms uses a novel, aquaponic system to grow produce.  In this system, both plants and fish are grown in a symbiotic water system.  The fish naturally create waste products, or fertilizer, which is pumped through the Garden Fresh closed system to the plants.  The plants use the fertilizer to grow and in turn also purify the water.  The cleaned water is then pumped back to the fish holding tanks, completing the loop.

Garden Fresh Farms uses aquaponics to grow produce through two different systems.  The first is a vertical system, where plants are grown on densely packed shelving straight up into the air.  These indoor farmers also grow plants in orbiting gardens- large eight by four foot rotating drums.  Currently, Garden Fresh Farms grows lettuce and herbs using these systems but is looking to expand in the near future.

The Garden Fresh farming methods use far less resources than traditional outdoor methods.  The plants are grown at much higher density than is possible with normal agriculture.  The vertical growth shelving units are packed tightly together, allowing four shelves to obtain light from one fixture.  The orbiting gardens can also be stacked nine feet high.  These features allow plants to be grown at very high density; Garden Fresh Farms can grow an equivalent one hundred acres of crop in a one square acre building.

Garden Fresh Farm’s disruptive growing structure minimizes the amount of resources needed for plant growth.  Their system uses 90% less water and 50% less energy than traditional outdoor farming methods.

It’s no secret.  Winter is a rough time in Minnesota to find good, fresh produce.  The food is often overripe and looks like it’s been there all week.  However, if you stumble upon Garden Fresh Farms produce in your local Lunds & Byerlys or Kowalski’s, the produce will be extremely fresh, even in January.  Twenty-four hours fresh to be exact.

Often the problem with produce distribution is getting the food that very last mile to the consumer.  Farms are often in rural areas, far from dense concentrations of people.  With the Garden Fresh Farms system, produce can be grown anywhere.  Right now, the company grows food in a warehouse in Saint Paul.  They can harvest their product in the morning, send it off to a distribution center by noon, and have the food on the shelves the very next day.  This whole process reduces food spoilage and waste and increases the nutritional value of the food.

The indoor growth system also means that all Garden Fresh Farms products are pesticide-free, a huge bonus for many consumers.

Garden Fresh Farms not only provides local, fresh food.  The company also has a deep-rooted social component. 

Garden Fresh Farms provides year-long farming jobs.  A total of twenty-five jobs would be created by converting one pole barn into a Garden Fresh Farms indoor growth facility.  The company has their very first public-private partnership in the works to begin in June 2016 in New England.  Garden Fresh Farms will convert an old, unused building into a farming factory, providing the over 30M people within a 100-mile radius of that site with local, fresh produce.  And jobs.

Garden Fresh Farms is a Community Supported Agriculture (CSA) farm.  Consumers can buy produce directly from the company to support local farmers.  In Garden Fresh Farm’s program, consumers sign up for 12-week increments and receive weekly bags of fresh produce plus recipe ideas.  The bags can be dropped off at several locations around the Twin Cities area. 

The benefits of the Garden Fresh Farms system don’t stop there.  The company’s unique produce growing process could actually help fight climate change.

Plants need carbon dioxide to grow.  Plants use carbon dioxide during photosynthesis- the process by which green plants convert sunlight into chemical energy which is used to power cellular functions.  Plants store the chemical energy generated during this process as the carbohydrate glucose, which later can be converted into the essential cellular fuel ATP.

Plants love carbon dioxide.  But we humans usually think of the substance in a negative manner.  Carbon dioxide is a greenhouse gas and makes up the largest percentage of all greenhouse gas emissions.  Excessive carbon dioxide production alters Earth’s normal carbon cycle and adds the heat trapping gas to the atmosphere, contributing to the gradually warming planet.

During photosynthesis, green plants use light and water to make their own food from carbon dioxide.  Plants use up the carbon and release oxygen at the end of the process, sequestering something that we don’t want and transforming it into something useful.

Farms are usually in rural areas, often very close to ethanol plants which produce carbon dioxide byproducts, something the Earth definitely does not want.  However, with the Garden Fresh Farms system, this carbon dioxide byproduct could be pumped to the indoor farms and sequestered by the growing produce through photosynthesis.  The plants could actually be used to “recycle” these carbon dioxide byproducts and convert it to something more useful for us all- food.

Garden Fresh Farm’s disruptive technology has earned them several awards and national recognition.  The group won the 2013 MN Cup Clean Tech and Energy Division and also won the Midwest Regional Clean Tech Open Competition and National Clean Tech Open Global Forum that same year.  In 2014, the company earned a Progress Minnesota Award, Eureka! Award, Green Products award from Saint Paul, and Sustainability Award from the City of Maplewood.

Two years ago, Garden Fresh Farms developed and launched a company called MNPHARM using the same aquaponics technology.  Check back later when we talk about MNPHARM and the potential to use tobacco plants as individualized medicine platforms.     

Wanted- More Wet Lab Space for Minnesota's Life Science Entrepreneurs

Last week, Life Science Nexus was privileged to tour the Worthington Biotechnology Advancement Center (BAC) and developing wet lab space with Worthington Regional Economic Development Corporation (WREDC) Executive Director Abraham Algadi. 

Click here to access our previous story about the BAC wet lab incubator. 

The BAC and associated incubator have a great opportunity to begin to fill a gaping hole in our life science startup space in Minnesota.  It’s no secret.  We in Minnesota have precious little wet lab space for our life science entrepreneurs.   

But what is the real utility of a wet lab space?  How can it spur innovation and entrepreneurship?  What can the Worthington BAC incubator bring to the table?

The Worthington Bio Science Conference wrapped up last week with a panel discussion surrounding the BAC lab build-out, what needs to happen to complete the space, and what value the lab would add to the community.

This expert panel was led by non-longer “homeless” life science entrepreneur Goutham Vemuri, Agricultural Utilization Research Institute (AURI) Project Development Director Harold Stanislawski, and AURI Senior Director of Science and Technology Rod Larkins.

Lack of access to a wet lab space is a major barrier to success for life science entrepreneurs.  Unlike some other science disciplines such as robotics, life science companies require critical infrastructure and equipment like centrifuges, fume hoods, and sub-zero freezers to generate intellectual property.  A life science startup is not really something that can be launched out of a basement.

Minnesota has very limited wet lab space for non-institute associated scientists, especially outside of the Twin Cities area.  AURI is stepping up to fill these gaps at their Crookston and Marshall facilities in western Minnesota.  Vemuri himself found a great home to make progress on his proof of concept at the AURI Marshall facilities. 

The 2000 square foot wet lab area being build in Worthington will provide space and infrastructure for the “homeless researcher” in southwestern Minnesota, helping to build up the entrepreneurial community in the city.  The lab space has great potential beyond this application.  The area could also be used by the larger companies in Worthington, like the animal vaccine developer Newport Laboratories, for processes such as product validation.  Training and other STEM outreach initiatives could also take place using the lab equipment.

The WREDC and city of Worthington continue to bring the BAC wet lab closer to a concrete reality.  The community is motivated and pointed in the right direction.  We at Life Science Nexus and across the state look forward to watching this story unfold.

 

Minneapolis-based LogicStream Health Leverages Health Informatics and EHRs to Improve Health Outcomes

The expanding Minneapolis-based company LogicStream Health developed a clinical process measurement platform to improve the quality of patient care and lower overall costs to healthcare systems.  The LogicStream Intelligence Platform reduces unnecessary variations in patient care and helps healthcare systems quantitate and improve best practices.

“Being able to measure the process of care is a key to clinical quality improvement.  That may seem self-evident since if you can’t measure a process, you can’t improve it.  However, despite its importance there is a significant gap in this area at most health systems,” explains Dr. Dan Rubin, Chief Medical Officer at LogicStream Health.

But what exactly is process of care and how can it be measured? 

Let’s say you need to have a knee replacement surgery to relieve symptoms of osteoarthritis.  There are many different pieces of care surrounding that surgery, beginning even prior to the day of operation.

First, you go through pre-operative assessments, dredging through your current medications and dosages, including a list of medications you might have been taking to prepare for surgery.  Then comes the actual surgery.  Lastly post-operative procedures occur, including prevention of any hospital acquired conditions.

What dictates this process of events and how do care providers know what protocols to follow when administering the care?

It boils down to Electronic Health Records, or EHRs.  In a nutshell, EHRs are the updated, 21st century version of the paper patient chart.  These digital EHRs are much more fluid and up-to-date than their predecessors.  They contain all the patient’s medical records and personal history and allow that information to be shared in a secure, seamless manner with all the patient’s care providers.

But EHRs go beyond this little snapshot of individual medical information.  Healthcare systems have built best care practices, or exact protocols detailing the steps to patient care, into the EHR.  These best practices have similarities regardless of the healthcare system.  But even when the best care practices are in place the problem lies in the human component.

“Obviously humans are fallible when it comes to following process and remembering to take every last step. …What’s challenging for [the healthcare systems] without LogicStream is really to measure how well these things are functioning and whether they are working as intended to drive outcomes,” explains Dr. Rubin. 

Once a best practice is standardized and built into the EHR, healthcare system teams usually need to tweak and improve these protocols to obtain the best outcome possible.  They also need to measure the level of best practice compliance across care provider teams.

Healthcare systems use the LogicStream Intelligence Platform to pull information from the EHR, analyze that information, and determine if their best practices are- or aren’t- working to drive the expected outcomes.  The LogicStream Platform makes any iterations and improvements to these best practices and compliance measurements possible.  Without LogicStream, these healthcare systems are basically “flying blind” and have no discreet way to measure their clinical process.

For example, LogicStream was used by one client to standardize care in order to prevent catheter-associated urinary tract infections (CAUTI), a common hospital acquired condition. LogicStream standardized the catheter use process, controlling which patients actually had catheters inserted and standardizing the process of catheter removal.  LogicStream reduced the number of catheters in use, decreased the rate of UTIs, and minimized unnecessary costs to the health system.

The eighteen person LogicStream team of informaticists and healthcare experts has clients “in every geographic region of the US,” says Dr. Rubin.  This growing company graduated from the TreeHouse Health accelerator in December and transitioned into a new space in the North Loop region of Minneapolis to continue the development process.

It’s a very exciting time for LogicSteam Health and other companies operating in health informatics- the crossroads where “clinical medicine, workflow, data, and the EHR all come together.” 

“I think we’re on the verge of a revolution around informatics where the pace at which we can impact and improve care is really starting to increase. …We’ll be able to standardize what happens on a much larger scale and much more effectively.  All this is really due to these key disciplines coming together and being brought to bear on the problem of unnecessary variation of care,” emphasizes Dr. Rubin.

Minneapolis Team Designs Card-Sized Epinephrine Auto-Injector to Increase Carrying Compliance in Severe Allergy Sufferers

A Minneapolis team has developed a slimmer, sleeker alternative to the EpiPen to increase carrying compliance and ensure that life-saving medications are on hand in emergency situations.  AdrenaCard brings peace of mind to food allergy sufferers and proves that perseverance, research, and product design pay off in the end.

Up to 16 million people in the United States are at risk for anaphylactic shock- a potentially fatal allergic reaction that occurs rapidly after exposure to certain proteins or toxins.  Currently, the EpiPen is the standard of care to mitigate this reaction. 

The EpiPen delivers a measured dose of epinephrine into the body.  Epinephrine, also known as adrenaline, activates the body’s fight-or-flight response, stimulates the heart, and increases blood flow to elevate breathing levels and relieve anaphylaxis symptoms long enough for a patient to get to a care center to receive further treatment.

Epinephrine is highly effective in temporarily relieving symptoms of anaphylaxis.  The problem lies in the method of drug delivery.  The EpiPen is bulky and highly inconvenient to carry.  Of the 16 million people at risk for anaphylactic shock, less than 25% actually own an EpiPen or other auto-injector to deliver epinephrine.  Less than 50% of this device-owning population carries the pen at all times, creating a 90% or 14.6M patient care gap.

“We found that two biggest issues with the products on the market today are their cost and the carrying compliance,” says Tyler Ebert, AdrenaCard CEO and Co-Founder. 

The average EpiPen on the market today costs $260.  Most doctors prescribe at least two of these devices, amounting to $520 of total expense.  EpiPens and other auto-injector devices are reimbursable by insurance.  However, most patients have high deductible healthcare plans and end up paying a lot of this cost out-of-pocket. 

The AdrenaCard team of Tyler Ebert and Chris Kuehn set out to improve upon this standard of care while students at the University of Minnesota (UMN).

Tyler Ebert was drawn to the UMN specifically to study entrepreneurship and has a background in restaurant development and food counseling.

As a food counselor at the university, people would often come to speak with him about their food allergies.  Even though they realized the importance of the device, many would not have their auto-injector on them.  Tyler dug into the details surrounding auto-injectors and discovered the high rate of non-compliance in device carrying and the massive market for auto-injectors.  In 2014 alone the auto-injector market had $1.3B in sales and continues to grow.

The idea of an improved device to deliver epinephrine was compelling from a clinical, personal, and business perspective.  Most importantly, Tyler wanted to improve the situation for these food allergy patients.

Tyler formed a partnership Chris Kuehn, who had logged time in medical device innovation at both Boston Scientific and Precision, Inc.  AdrenaCard was born.

“[…] what we created is a device that delivers the same life saving medication [as the EpiPen], with a form factor that is the size of a credit card,” explains Tyler.

The slimmer, smaller size of the AdrenaCard auto-injector allows it to be easily carried in a pocket, wallet, or attached to a key chain, making the device more likely to be on hand in case of emergency.

The AdrenaCard delivers the exact same drug as the EpiPen.  However, the AdrenaCard has a beautifully improved form factor and design because the team invested extensive time and effort to understand severe allergy patients and their lifestyle.

The pair initially struggled to gain traction and raise their first round of seed capital in the Twin Cities area due to a crowded market and especially busy time of the year.  They sought out partners beyond the Twin Cities area and found a great resource base in Alexandria, Minnesota.

Alexandria and the expertise of central Minnesota often gets overlooked.  But this self-sustaining area has real expertise in contract manufacturing of scientific and medical devices, which they export around the world.

The AdrenaCard team linked up with their now lead investor, UMN Reagent and serial entrepreneur Thomas Anderson, who introduced them to the greater Alexandria community.  Within this group, the AdrenaCard pair found people “[…] who would not only invest in us, but sat with us as advisors and mentored us.  They helped to build us,” explains Tyler.

AdrenaCard raised their first round of capital with this amazing partnership in Alexandria.  To date, this is the largest amount of seed funding raised by undergraduate students in the history of Minnesota.  The team is currently raising a Series A to get them through FDA clearance as early as 2017.

AdrenaCard also found a great partner for product development in Minneapolis-based Worrell Design, a company that specializes in medical device design and human factors.  Working with Chris Kuehn, the Worrell team has brought the AdrenaCard device to the level it’s at today.

AdrenaCard recently competed in the US National Competition of Global Student Entrepreneur Awards, which attracts top student entrepreneurs from about the world.  The team ranked as the #2 student-owned business in the country for 2015, garnering AdrenaCard national recognition.

The AdrenaCard team proves the value of hard work, dedication, and perseverance in reaching your goals.  They have brought national media attention not only to themselves, but the to the great work being performed in the Twin Cities entrepreneurial scene as a whole.

Healthcare.mn Energizes the Twin Cities Healthcare Entrepreneurial Community. What's in Store for 2016?

Glafira Marcon is on a mission to learn as much as she can about healthcare.  The Macalester College alumnus joined the Healthcare.mn team shortly after graduation and took over as lead organizer this past October.  She has some fresh, new directives in store for the group in 2016.

Healthcare.mn, the Twin Cities community for healthcare innovation and startups, operates with the vision that “Minnesota is the best place to launch a healthcare startup,” explains Glafira.  The group’s main focus is “to bring together healthcare innovation enthusiasts to catalyze the community, energize it, and support it.”

Healthcare.mn lowers barriers to success for healthcare startups and entrepreneurs by making information and connections more accessible.  The group serves as a platform for exposure for these innovators and delivers “access to resources as well so that they can find a path to elevate and spread their solutions,” says Glafira.

The now over 1,100-member strong group was originally founded by local entrepreneurs Peter Kane, Thompson Aderinkomi, and Solome Tibebu in 2013.  The trio noticed the general lack of a community-based supportive group when launching their own startups and wanted to build a place where Twin Cities healthcare entrepreneurs could share ideas and build their network. 

Membership has rapidly grown over the past three years and Healthcare.mn continues to diversify in scope as the group expands, offering something for any entrepreneur operating in the Twin Cities healthcare space.  “Members find immense value in our group, whether it’s in the content of a discussion or just being in the same room with all these amazing people,” says Glafira.

The Healthcare.mn team continues to expand as a few more entrepreneurs were recently added to the organizing team.  These intrepid innovators mirror Glafira’s own passion and curiosity about healthcare and will complement her community and global health focus with experience in health tech, management/operations, and finance/investment.

Healthcare.mn events have always provided general education about hot healthcare topics, distilling down complex information and making it more accessible.  The group constantly works to connect startups with employees, investors, or end customers and offers entrepreneurs the space and opportunity to interact with key Twin Cities influencers.

Some new initiatives and programming have been added to the Healthcare.mn docket this year to continue to provide value to the Twin Cities healthcare community. 

One new series will help entrepreneurs better articulate the real issues they are trying to solve in healthcare by asking, “what is the real problem?”.

“Through experts at our events, we’re sharing frameworks for how startups can drill down and identify the problem they are trying to solve, get connected to people who are impacted by that problem, and design solutions that meet their needs and provide a good user experience,” sums up Glafira. 

Other Healthcare.mn events will feature stakeholders from specific industries or companies within the healthcare field, outlining the major problems they are facing.  “It’s them saying, we need innovation in this space.  We need startups to solve these problems. We hope this will enable existing startups to align their products and services with these real needs, or inspire people to start new ones,” explains Glafira.

Maintaining lines of communication and enthusiasm between events stands as a major initiative for Healthcare.mn in 2016.

“At our events, we have a ton of energy, a lot of conversations.  People are really excited.  It starts to drop off a few days after these events.  So what do we do between events to make sure that people are still talking and collaborating?  How do we facilitate that?” asks Glafira.

The group plans to rebuild and relaunch the Healthcare.mn website as part of the solution to provide an open forum for community conversations and connections.  In addition, they plan to host office hours with experts and provide a platform for sub-groups with specific interests to form.

Stay informed of Healthcare.mn’s upcoming events by joining the Meetup Group keep up with the conversation on LinkedIn.

Join Healthcare.mn at their next event focused on Service Design on March 14th.

 

 

Minnesota Startup Geneticure Designed Gene Panel to Direct Hypertension Treatment and Control High Blood Pressure Faster than Standard of Care

Geneticure- a startup with close ties to Rochester, Minnesota- created a panel of genes involved in hypertension to support decision making processes for clinicians and to control the disease faster for patients.

Seventy-eight million Americans, or every one in three, are afflicted with high blood pressure.  Five million new diagnoses spring up every year.  Over fifty percent of the US hypertension population, or thirty-seven million people, do not have the disease under control, often because they are taking the wrong medications.

The current guidelines, or standard of care, for treating hypertension targets three systems: the kidneys, the blood vessels, and the heart to inhibit sodium reabsorption, induce vasodilation, or reduce total cardiac output.  According to the standard of care, every patient presenting with hypertension begins treatment with the same drug, usually a diuretic.  The drug is slowly titrated up until the maximum tolerable dose is reached. 

If the first round of drug treatment does not control the hypertension, a second drug class is added without taking the patient off the first drug and the titration process is repeated.  If blood pressure levels still remain uncontrolled, a third class of drugs will be added into the regiment. 

This process is a very long and frustrating road to controlling hypertension, lasting up to twelve to fifteen months and adding unnecessary costs to the healthcare system.  Even with complete medication compliance, 40% of hypertension patients do not have their condition under control due to this trial-and-error process.

Geneticure aims to disrupt this paradigm of treatment and control hypertension faster than the standard of care by providing a more personalized, individual approach to hypertension treament.

The company has “identified and patented a unique panel of genes that are fundamental causal factors behind the disease and the corresponding responses that the patient could expect based on these various classes of drugs,” explains Geneticure Co-Founder and President Scott Snyder.  He thinks that Geneticure can slash the time for controlling hypertension down to two to six weeks.

“We’re eliminating those unnecessary office visits.  We’re eliminating unnecessary prescriptions.  But also we’re getting one of the deadliest diseases in the US under control quite a bit quicker. […] The risk factors of heart disease, stroke, and heart attack go through the roof when you don’t control the disease,” Snyder explains.

The Geneticure team designed a post-diagnosis product to help clinicians make more informed decisions to treat and manage hypertension patients. 

The startup focuses on pharmacogenetics- or how an individual’s DNA affects their metabolism and response to certain drugs.  They created and patented a panel of genes involved in hypertension regulation.  Genes included in the panel were curated from over twelve thousand peer-reviewed manuscripts.  The presence of certain alleles- or variant forms of the same gene with slightly different DNA sequences- of these genes correlate with a particular response to drug treatment. 

To begin the Geneticure testing process, hypertension patients have a sample of DNA taken right in their doctor’s office.  The Geneticure DNA collection kit comes in a clean, freshly designed box with the inscription “say ahh…” on the inside thanks to Snyder’s extensive Consumer Packaged Goods (CPG) background.  The kit contains two buccal cheek swabs for painless, non-invasive DNA collection.  After the sample is taken, it’s lysed in two small vials, which are bar coded to protect patient identity.  The samples are then shipped off to the CLIA (Clinical Laboratory Improvement and Amendments of 1988) certified lab at the University of Arizona (UA).

Once at the lab, the DNA is extracted and the Geneticure proprietary assay run.  A report of the findings is returned to the clinician with the patient’s genotype- the DNA sequence at these targeted alleles- and the predicted patient response to drug therapy, including the literature supporting the recommended drug treatment. 

For example, if a patient has the genotype, or alleles, EE for hypertension gene LSN, Geneticure would know that gene LSN relates to blood vessel function and might predict that a vasodilator be the first line of defense in controlling this particular patient’s hypertension.

The Geneticure team is stacked with three National Institutes of Health (NIH) funded scientists who know a thing or two about cardiology and genetics.  The company was begun by the Snyder brothers, President Scott Snyder and Chief Operating Officer Eric Snyder.  The latter Snyder performed his thesis work in cardiology at Mayo Clinic in Rochester and then went on to UA, where he collaborated with genetics expert and now Geneticure Chief Scientific Officer Dr. Ryan Sprissler.  Sprissler runs the UA Genetics Core Facility and receives all the Geneticure DNA samples.  The fourth co-founder and Chief Clinical Officer, Dr. Tom Olson, serves as Assistant Professor of Medicine and Consulting in Cardiovascular Diseases at Mayo Clinic. 

Late last year, the team added a second business man to the team, Ben Bowman.  Bowman has an extensive background in startup development and was the Founding CEO of General Blood, a company that optimized the human donated blood market.

The group launched a retrospective stage phase one clinical trial early last year to demonstrate the efficacy of the gene panel in directing hypertension treatment and found quite a bit of success.

“…we were more than twice as good as the standard of care in predicting that first drug class that was successful,” explains Snyder.  In one particular case, Geneticure would have controlled a hypertension patient nine months faster than the standard of care. 

Geneticure also thinks they can improve patient therapy compliance “by providing a personalized medication solution. […] [Patients] are going to be more likely to take that drug if they know it was a solution that was developed for them,” explains Snyder.

Snyder predicts, “Without question, at some point in the future, your doctor will not prescribe a drug for hypertension without you taking our test.”