biotech

Four Rochester Biotech Teams Showcase Technology at Seventh Walleye Tank Business Pitch Competition

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Four Rochester biotech startup teams competed in the seventh Walleye Tank business pitch competition this May in Minneapolis for the chance to enter into the semifinal round of the Minnesota Cup. Eighteen total startups pitched their technologies at this event. At the end of the competition, Twin Cities startups Ascension and Morari Medical walked away as overall winners.  

Startups enter into this biotech competition in two different categories: the Junior Angler or Professional Division. Junior Anglers are newer teams with ideas at the pre-prototype stage. Professional teams are further along in the business development process and may have a minimal viable product, market traction, and sales. 

Teams are judged by a panel of startup and business development experts called Walleyes. This year, Junior Anglers were judged by: Perry Hackett, serial entrepreneur and Professor of Genetics, Cell Biology, and Development at the University of Minnesota; Susan Kimmel, market research expert and Gopher Angel; Traci Downs, serial entrepreneur and founder of Collider Coworking and Area 10 Labs; Mary MacCarthy, entrepreneur and Venture Center Program Manager with the University of Minnesota’s Office of Technology Commercialization; and bio tech expert Fernando Bazan. Professional teams were judged by: Sara Russick, entrepreneur and founder of investment groups Gopher Angels and Capita3; Julie Henry, Director of Business Operations for Mayo Clinic Ventures and Mayo Clinic’s Department of Business Development; Russ Straate, Associate Director of the University of Minnesota Venture Center; and Meg Steuer, Manager of Forge North with Greater MSP.

Four teams from Rochester participated in Walleye Tank including Smart Lead and MD to Me in the Junior Angler Division and Phenomix and Phraze in the Professional Division.

Smart Lead, presented by Dr. Alaa Sada, is tackling an uncomfortable garment, the radiation shield, that’s required to be worn by healthcare providers anytime they are exposed to radiation. The vest weighs about ten pounds and is often worn for very long hours. Use of the garment can lead to discomfort, bodily pain, burnout, and musculoskeletal injury. To solve this problem, the team behind Smart Lead is developing a more ergonomic vest that will continue to provide radiation protection with increased comfort due to added technology. The Smart Lead team of Mayo Clinic physicians is now working with Mayo Clinic’s Department of Business Development and Division of Biomedical Engineering to develop their first prototype. They estimate a $2.75M market for their product at Mayo Clinic alone. 

MD to Me, presented by Mayo Clinic graduate student Chris Paradise, aims to “take back control of high blood pressure.” Approximately 100M Americans are affected by high blood pressure. Only 50% of these patients have the disease under control with about 1,000 deaths occurring each day from hypertension related conditions. To solve this problem, MD to Me is developing an IoT blood pressure cuff paired with an app platform to provide real time blood pressure data to patients. Blood pressure data will additionally be monitored by a physician. The team aims to reduce medical and ER visits with their technology.

Phenomix Sciences, presented by COO Ross Higgins, is a Mayo Clinic startup founded by two physician researchers. The business aims to provide a precision medicine, multi-omics approach to treat obesity. Over 40% of the US adult population is obese, leading to $480B of direct costs to the healthcare system annually. In addition, two-thirds of obesity patients do not respond to their prescribed treatments. To solve this problem, Phenomix is pairing an AI-driven algorithm with a panel of biomarkers, which they’ve licensed from Mayo Clinic, to develop the first blood test to segment obesity patients for therapeutic targeting.

Phraze, presented by COO Jack Schneeman, has developed an AI-driven medical scribe to automate a significant portion of physician medical note taking requirements. More than 50% of physician time is spent on Electronic Medical Record (EMR) documentation. This amount of documentation is the number one cause of physician burnout. Burnout, in turn, can cause a 300% increase in the medical error rate. Phraze’s technology was shown to save about 1.5 hours per day for physicians based on simulations and testing. 

Twin Cities-based team Ascension was named the overall Junior Division winner of Walleye Tank. This startup, presented by product design engineer Lyndsey Calvin, is developing innovative solutions for transgender health. Vaginoplasty, a current care option for transgender women, involves the surgical reconstruction of the vagina. This procedure has a 50% complication rate, costing over $25,000 per patient to treat. To solve this problem, Ascension is creating a single use flushing stent to provide an improved care option. The stent is placed in the vagina during the vaginoplasty procedure and is replaced monthly for the first ninety days with a larger sized stent. This process replicates dilation and reduces the burden of compliance barriers for vaginoplasty patients. Ascension is currently targeting a $1.5B marketing that’s growing at a 41% rate.

Minneapolis-based Morari Medical won this spring’s Professional Division of Walleye Tank. This startup, presented by CEO Jeff Bennett, is developing the first ever device-based solution to premature ejaculation (PE). PE is the number one sexual dysfunction in men. It affects one in three men and results in decreased quality of life for both men and women. The Morari team is addressing this problem through neuromodulation with a small, band-aid sized device to inhibit neural activity and delay an ejaculation.

Congratulations to all the Walleye Tank participants. Best of luck to Ascension and Morari Medical in the Minnesota Cup! Look for Walleye Tank to return to Rochester for the eighth edition on December 6th. 

Minnesota's Medical Alley Reports $2B in Exits, $731M Raised in HealthTech Sector in 2018

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Minnesota’s Medical Alley reports strong and consistent growth in 2018, according to a recent investment report from Medical Alley Association.

In 2018, healthtech companies in Medical Alley raised $731M, a slight decrease from the $759M raised in 2017. This represents the second consecutive year Medical Alley companies have raised over $700M of funding. This included large investments in digital health, with nineteen companies raising $320M. This was followed by $260M raised by forty-eight companies in the medical device space. $144M was also raised by eighteen biotech companies in Medical Alley. 

In total, nineteen healthtech companies raised over $10M. Top raises included $200M from health insurance company Bright Health, $70M from Bind, also a health insurance company, and $58M by Relievant Medsystems, a company developing solutions for chronic back pain.

Medical Alley additionally experienced significant exits with a declared total value of $2B. This included the acquisition of ABILITY Network, a company providing solutions to reduce costs for healthcare providers and payers, by cloud company Inovalon. Inspire Medical, a company developing sleep apnea treatments, had an IPO on the New York Stock Exchange, raising $108M. Biomedical company NxThera was sold to Boston Scientific for $400M. And microbiome company Rebiotix was acquired by the Swiss based Ferring Pharmaceuticals.

Despite these acquisitions, many of these companies have remained in Medical Alley. ABILITY Network has expanded within Minnesota through the hiring of new employees. Francis Medical, a spinout of NxThera after its acquisition, was also kept in Minnesota.

For more detailed investment reports on healthtech in Minnesota, head to the Medical Alley Association website.


About Medical Alley Association

Founded in 1984, the Medical Alley Association supports and advances the global leadership of Medical Alley’s healthcare industry, and its connectivity around the world. MAA delivers the collective influence, intelligence and interactions that support Medical Alley.

State of the Art Cancer Therapeutics Manufacturing Headquarters Celebrates Grand Opening in Rochester Next Week

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This month Rochester clinical stage biopharmaceutical company Vyriad is set to open the doors at their brand new 25,000 square foot facility. This custom build-out, constructed on leased space at the IBM Campus, will be the new Vyriad headquarters and manufacturing site. The facility is expected to increase the capacity of the company to produce and develop viral oncolytic cancer therapies and to potentially add new biotech jobs in Rochester.

Vyriad is developing viral therapies, based on Vesicular stomatitis virus (VSV) or measles platforms, to treat a variety of cancers. Spread and localization of Vyriad’s oncolytic therapies can be monitored non-invasively to ensure viral targeting to the cancer site. The company currently is running several Phase I and Phase II clinical trials to test the safety and efficacy of their viral therapies in patients.

Custom build-out of the Vyriad facility in northwest Rochester began this May, propelled by $9M of convertible debt financing. This funding included participation from Mayo Clinic, Rochester Area Economic Development, Inc., and the Southeast Minnesota Capital Fund.  

Photo courtesy of Vyriad.

Photo courtesy of Vyriad.

The new facility includes two clean room suites where the viral manufacturing process is initiated and product is purified. Virus will be packaged and labeled in a separate room for compliance with new FDA regulations for Good Manufacturing Practice (GMP) investigational drugs. These rooms are also modular so they can be taken apart and re-organized as needed for future growth within the facility.

The buildout also includes an entire corridor dedicated to quality testing of both Vyriad’s end viral oncolytic products and of patient samples collected through sister company Imanis Life Sciences for sponsored clinical trials.

Vyriad’s leased space on the IBM Campus includes an additional 18,000 square feet for any future expansions of the biotech company at this location.  

Design and buildout of the Vyriad facility was very intentional and forward thinking, with cleanliness being of utmost importance. The manufacturing, purification, packaging, and testing processes will all be uni-directional, with no backward flow of products or personnel within the isolated clean rooms to eliminate contamination. The rooms are additionally airlocked to restrict air and particle flow. Any breach or contamination in the system would shut down all production for about one month.

After an eight-month construction process, Vyriad will host an invitation only grand opening of its new manufacturing facility and headquarters on Wednesday January 30th. Buildout of the project was led by Benike Construction. RSP Architects served as lead design, with Madison-based Flad Architects crafting the Good Manufacturing Practice areas of the facility.

The new facility is expected to vastly increase the product run capacity of the company; currently Vyriad utilizes Mayo Clinic as a Contract Manufacturing Organization (CMO) for their viral therapies. The increased square footage also allows Vyriad to develop and create new viral products to add to their pipeline, increasing the capabilities of the company and allowing for potential expansion of their preclinical team. 

Photo courtesy of Vyriad.

Photo courtesy of Vyriad.

Vyriad was founded by Mayo Clinic virologist Dr. Stephen Russell, Mayo Clinic oncologist Dr. Kah Whye Peng, and University of Miami cell biologist Dr. Glen Barber in 2012. Dr. Russell has served as CEO since 2016.

Learn more and follow the progress of this emerging local biopharmaceutical company on their website http://www.vyriad.com/.

Five Local Biotech Student-Led Teams Advance to Walleye Tank

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Allisa Song, Nanodropper.

Allisa Song, Nanodropper.

Last Thursday local student-led innovation stole the limelight at the Entrepreneurial Student Showcase + Walleye Tank Student Qualifying Round, a collaboration between Saint Mary’s University of Minnesota Kabara Institute for Entrepreneurial Studies, Collider Coworking, and the Mayo Clinic Office of Entrepreneurship. Seventeen different student teams from around the region competed in the event. Twelve of these teams pitched with the hope to enter Walleye Tank, a Minnesota-based biotech business pitch competition. From this student qualifying round, five teams were deemed ready to compete in Walleye Tank, which will take place tomorrow in Rochester. Advancing teams included Nanodropper, NeuroCog, Malleus, UVCanopy, and Intelligent Parking Solutions.

Nanodropper, presented by Mayo Clinic Medical Student Allisa Song, is addressing wasted eyedrop medications from unnecessary overflow during application of meds; the normal amount of liquid dispensed from eye drop bottles is five times that which can be absorbed by the human eye, according the Nanodropper team. In glaucoma treatment alone, excessive waste from eye drops can cost up to $500 per bottle. This waste is a large problem for low income patients or patients that run out of medication before their prescription can be refilled. To solve this problem, the Nanodropper team has developed a medical grade, single-use silicone eye drop adapter that reduces the size of dispensed eye drops to a volume that can be absorbed by the human eye to reduce medical eye drop waste. This adapter has a universal fit and is patent-pending. The team plans to deliver the product to customers through eye care clinics at a cost of $12.99, resulting in an 86% profit margin. By 2020, ~80M patients will be diagnosed with glaucoma, resulting in an estimated market size of $90M in revenue in the US market alone. Nanodropper qualified for the Mid-Level Reeler division of Walleye Tank.

Logan Grado and Ian Kitchen, Malleus.

Logan Grado and Ian Kitchen, Malleus.

University of Minnesota-Twin Cities students Logan Grado and Ian Kitchen won first place in the Junior Angler Division with Malleus, a hearing aid technology startup. By 2020 an estimated 45M people will be diagnosed with mild to moderate hearing deficiencies, requiring the use of a hearing aid. However, hearing aids are normally tuned by audiologists in a controlled clinical setting, which can be non-functional in a real-world environment. Consequently, when patients need to have their hearing aid adjusted, they have to return to the audiologist, resulting in a costly and inefficient process. Malleus aims to pair artificial intelligence with Bluetooth capable devices to create more personalized, self-directed hearing fits for patients to reduce the need for excessive hearing aid tuning in a clinical setting.  

James Perreault, UVCanopy.

James Perreault, UVCanopy.

Mayo Clinic Florida researcher and physician team of David Restrepo, Daniel Boczar, Toni Turnbull, and Karim ReFaey won second place in the Junior Angler division with their concept, NeuroCog. Brain surgery patients, the team explained, require frequent pre- and postoperative evaluations of cognitive function, which can be very time and resource consuming. To address this issue, they propose the development of a tablet-based application providing standardized, automatized cognitive testing to complement routine postoperative monitoring of neurosurgery patients. This app would incorporate artificial intelligence-based voice, facial, and text recognition to perform cognitive assessments, targeting the 13.8M neurosurgeries occurring globally each year. 

Also qualifying for the Junior Angler Division of Walleye Tank, and winning the Audience Favorite Award, was Saint Mary’s University Finance Student James Perreault with his concept UVCanopy. UVCanopy is addressing the lack of sanitation on items like wheel chairs and other hospital equipment, primarily targeting nursing homes and rehabilitation centers. The UVCanopy uses germicidal UV-C light to kill bacteria in a tunnel-shaped device. Medical equipment could be pushed through the tunnel for sterilization purposes, additionally eliminating human error involved in the sanitation process and reducing dependency on hazardous sterilization chemicals. UVCanopy proposes to make profits through subscription sales and purchases of replacement parts. The team is currently working with the Saint Mary’s University Science Department to test different light volatility in the disinfection process.  

Sinibaldo Romero, Intelligent Parking Solutions.

Sinibaldo Romero, Intelligent Parking Solutions.

The final team to qualify for the Junior Angler Division of Walleye Tank was the Intelligent Parking Solutions concept, led by Mayo Clinic Post Baccalaureate Fellow Sinibaldo Romero. This concept aims to utilize data analytics to increase parking efficiencies in healthcare organizations. The team proposed using cameras in parking spaces to identify unused spots. The product would leverage machine learning to understand parking patterns for patients and staff to determine more efficient mechanisms for healthcare parking. Parking is a multi-million-dollar industry for healthcare institutions. Missed medical appointments due to lack of parking in the US is documented to cost $150B to healthcare institutions each year.

Student showcase teams were judged by Heather Holmes, Vice President of Marketing at Rochester Area Economic Development, Inc.; Chris Lukenbill, Founder at Fresh Edge; Sunny Prabhakar, Account Strategist at Corporate Web Services, Inc., Jon Ninas, Career Awareness Specialist at Mayo Clinic; Sam Gill, Workforce Development Manager at the Rochester Area Chamber of Commerce; and Brady Olson, Human Resources Administrative Assistant at Mayo Clinic. The Walleye Tank Student Qualifying Round was judged by Chris Schad, Director of Business Development for Discovery Square; Joselyn Raymundo, Founder of Rochester Home Infusion; Xavier Frigola, Director of Entrepreneurship at Rochester Area Economic Development, Inc.; and Shuai Li, Lab Manager at Mayo Clinic.

Watch all the Walleye Tank student qualifying round pitches on the YouTube channel. Catch these teams live as they pitch in Walleye Tank tomorrow starting at noon in Rochester. Walleye Tank is a free event that is open to the public.

Six Startups from across U.S. Aim to Improve Patient Care through Devices, Software, and Care Management in gBETA Medtech Fall 2018 Cohort

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 Minneapolis, MN – gBETA Medtech, a program of the nationally ranked accelerator gener8tor, has selected six startups for its Fall 2018 cohort from an international applicant pool. gBETA Medtech is funded by Boston Scientific with additional support from Mayo Clinic, the University of Minnesota and Medical Alley Association. 

“gBETA Medtech’s success this year is a testimony to the demand for even greater collaboration between early-stage ventures, influential institutions and corporate leaders,” said Dave Knapp, vice president, Corporate Research at Boston Scientific. “As we build more and closer relationships across this ecosystem, we move closer to our ultimate goal: an even greater impact on patient care, lives changed and lives saved.” 

 gBETA Medtech is a free, seven-week accelerator that works with medical device, healthcare-related software, biotech, and diagnostics startups for no fees and no equity. Each gBETA program is capped at six companies to ensure meaningful engagement with sponsors and other resources. Participants receive intensive and individualized coaching and access to physicians, researchers, successful entrepreneurs, angel investors, venture capitalists, and industry experts. The program is designed to help startups gain early customer traction on their product or idea, and establish metrics that can make them competitive applicants for full-time, equity-based accelerators or seed investment. 

“Demand for programs like ours is only growing in the wake of our first two cohorts’ success. We believe that the solutions these companies offer to address diverse clinical needs have the potential to be truly disruptive, and we can’t wait to integrate these companies into Medical Alley,” said Adam Choe, director of gBETA Medtech. 

 The gBETA Medtech Fall 2018 cohort includes: 

CorInnova (Houston, Texas) designs and develops a revolutionary soft robotic non-blood contacting biventricular cardiac assist device for the treatment of heart failure (HF) that would eliminate 40% of the adverse events associated with existing cardiac assist devices. 

CEO: William Altman | william.altman@corinnova.com | www.corinnova.com 

Drug Free Therapeutix (Indianapolis, Indiana) designs and develops an intelligent, networked non-invasive closed-loop vagal nerve stimulation (VNS) technology that uses artificial intelligence and machine learning to treat a variety of pain and gastrointestinal disorders. 

CEO: Stephen Hourigan | shourigan@dftxllc.com | www.drugfreetherapeutix.com  

HabitAware (Minneapolis, Minnesota) makes Keen, a smart bracelet that helps people manage compulsive behaviors including trichotillomania (hair pulling), skin picking, nail biting and more. 

CEO: Sameer Kumar | sameer@habitaware.com | www.habitware.com 

Nutrimedy (Boston, Massachusetts) improves the outdated care delivery model for clinical nutrition connecting patients with expert registered dietitians to provide education, support, and counseling for over 50 conditions through a web platform and mobile app.

CEO: Karolina Starczak | karolina@nutrimedy.com | www.nutrimedy.com 

Phraze (San Francisco, California) automates physician electronic medical record (EMR) data entry and documentation requirements utilizing an AI scribe. 

Co-Founder: Brandon McCutcheon | brandon@phraze.co | www.phraze.co 

Vital Health Links (Woodbury, Minnesota) specializes in helping medical practices and healthcare organizations realize new revenue and improve quality metrics through Medicare’s Chronic Care Management program. 

CEO: Saurin Patel | saurin@vitalhealthlinks.com | www.vitalhealthlinks.com 

Startups interested in learning more should contact gBETA Medtech Director Adam Choe (adam@gener8tor.com). For more information on the program and ways to get involved, please visit www.gbetamedtech.com. 

All Major Sectors in Medical Alley Break $100 million Raised for First Time

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Medical Alley’s third quarter ended with new industry records and new milestones set across the board. 27 Medical Alley-based companies raised $176,089,457 in Q3, the second-best Q3 in the last five years.

“Medical Alley's portfolio of growing companies across the healthcare spectrum continues to demonstrate that this region is the best place to solve healthcare's biggest challenges, regardless of what sector you are in.” said Shaye Mandle, President and CEO, Medical Alley Association.

Medical Alley device companies raised $90 million this quarter, continuing a steady growth trend that began in 2009. Biotech companies also set new milestones in Medical Alley, breaking $100 million in capital raised in a year for the first time in Medical Alley history. Digital Health investment continued its strong run with $32 million raised in the third quarter for a year-to-date total of $116 million.

Most noteworthy in Q3 is that all major sectors in Medical Alley broke $100 million in year-to-date funds raised for the first time.

The top-raising companies included Recombinetics with $34M in Series A funding, Urotronic Inc. with $20M in Series B funding, 4C Medical Technologies with $17M in Series A funding, and Vireo Health LLC and Cardialen each raising $16M.

To see the full report click here.

About The Medical Alley Association

Founded in 1984, the Medical Alley Association supports and advances the global leadership of Medical Alley’s healthcare industry, and its connectivity around the world. MAA delivers the collective influence, intelligence and interactions that support Medical Alley.

Press Release: Medical Alley Investment Report – Strong Start for 2018, but Loss of AITC Seriously Threatens Job Growth

Medical Alley Association released their first half investment report Monday, drawing attention to key developments taking place in the health technology industry. Medical Alley companies had a strong start to 2018, buoyed by new investments in biotech, with 45 companies raising $234 million in the first half of the year. Similarly, Medical Alley’s biopharma community had its best first half ever with $51.8 million raised by 10 companies, more than double the prior record from 2015.

However, the loss of the Angel Investment Tax Credit (AITC) is threatening job growth in Medical Alley. The fewest companies since the passage of the AITC raised money in the first six months of 2018, following the credits expiration.

“Clearly the loss of the Angel Investment Tax Credit has been detrimental to job growth in Medical Alley” said Shaye Mandle, President and CEO of the Medical Alley Association. “Lawmakers need to act to reinstate the credit, so that life-saving innovations and critical job creation can continue in Medical Alley, the global epicenter of health innovation and care,” Mandle said.

34 companies raised $4 million or less, the AITC cap, a 20% drop from the prior year, and a new low since the credit was first instituted.

About the Medical Alley Association

Founded in 1984, the Medical Alley Association supports and advances the global leadership of Medical Alley’s healthcare industry, and its connectivity around the world. MAA delivers the collective influence, intelligence and interactions that support Medical Alley.

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Press Release: gBETA Medtech Announces Summer 2018 Cohort

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Minneapolis, MN – gBETA Medtech, a program of the nationally ranked accelerator gener8tor, announced the six startups that were selected for its Summer 2018 cohort. gBETA Medtech is funded by Boston Scientific, with additional support from Mayo Clinic, the University of Minnesota, and Medical Alley Association.

gBETA Medtech is a free, seven-week accelerator that works with medical device, healthcare-related software, biotech and diagnostics startups. Each gBETA program is capped at six companies, and requires no fees and takes no equity. Participants receive intensive and individualized coaching and access to physicians, researchers, successful entrepreneurs, angel investors, venture capitalists and industry experts. The program is designed to help startups gain early customer traction on their product or idea, and establish metrics that can make them competitive applicants for full-time, equity-based accelerators or seed investment.

The gBETA Medtech Summer 2018 cohort consists of six startups selected from an international applicant pool. Descriptions for all six companies can be found below.

“As gBETA Medtech builds momentum with this second cohort, we’re encouraged by the increasing diversity of the applicants drawn to Medical Alley,” said Adam Choe, director of gBETA Medtech. “With companies from across the country focused on a wide range of patient needs, we’re confident that this group will maximize the opportunities to engage with mentors, investors and strategic organizations during our seven-week program and will bring the best of Minnesota’s medtech cluster back to their local markets.”

  • InterShunt (St. Louis, Missouri) designs and develops a catheter based minimally-invasive procedure, without an implant, to provide relief for millions suffering from heart failure.
    CEO: Harlee Sorkin | harlee@intershunt.com| www.intershunt.com

  • Lucia Health Guidelines (San Francisco, California) uses artificial intelligence and machine learning to facilitate clinician adherence to American Heart Association guidelines in order to close gaps in care.
    CEO: Mathew Rothway | mathew@luciaguidelines.comwww.luciaguidelines.com

  • Morari Medical (Minneapolis, Minnesota) is restoring confidence in male sexual health by eliminating the embarrassment and frustration of sexual dysfunction.
    CEO: Jeff Bennett | jbennett@morarimedical.comwww.morarimedical.com

  • Noleus Technologies (Houston, Texas) designs and develops a disposable device that mitigates postoperative bowel swelling to accelerate patient recovery after abdominal surgery.          CEO: Swarna Balasubramaniam, MD | swarna@noleustechnologies.com|www.noleustechnologies.com

  • Sunrise Health (Boston, Massachusetts) provides patients with mental health or substance use conditions 24/7 access to anonymous, text-based group support.                                          CEO: Shrenik Jain | shrenik@sunrisehealth.co| www.sunrisehealth.co

  • SuraMedical (Minneapolis, Minnesota) increases the consistency in chronic leg wound treatment by remotely monitoring critical aspects of chronic care.
    CEO: Marja Engel | marja.engels@suramedical.comwww.suramedical.com

    gBETA Medtech is now accepting applications for the Fall 2018 cohort. Applications are open to startups across the globe. Startups interested in applying should contact gBETA Medtech Director Adam Choe (adam@gener8tor.com). For more information on the program and ways to get involved, please visit www.gbetamedtech.com.

Press Release: Vyriad Announces Collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to Evaluate Oncolytic Virus in Combination with Anti-PD-L1 Antibody in Phase 1 Clinical Study

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ROCHESTER, Minn., July 18, 2018 – Vyriad Inc., a clinical-stage, privately held biotechnology company focused on the development of powerful first-in class oncolytic virotherapies, is pleased to announce a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to expand its ongoing Phase 1 clinical trial program in solid tumors to include a combination study of its lead asset, Voyager-V1, with avelumab*, a human anti-PD-L1 antibody. For more information on this novel immuno-oncology combination study, please see clinicaltrials.gov.

“We are delighted to be working with Merck KGaA, Darmstadt Germany, and Pfizer on this innovative combination treatment approach,” said Stephen Russell, M.D., Ph.D., CEO of Vyriad. “Voyager-V1 is being administered to inflame the tumors, and avelumab has been shown to release the suppression of the T cell mediated antitumor immune response in preclinical models.”

“We are encouraged by the potential of Voyager-V1, which has demonstrated early clinical activity in patients with solid tumors,” said Alise Reicin, Head of Global Clinical Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. and Canada as EMD Serono. “We look forward to investigating how combining Voyager-V1 with avelumab may advance patient care.”

“A primary focus of our clinical development program for avelumab is to evaluate the role and potential of immunotherapy combination regimens, in an effort to support patients with challenging cancers,” said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. “We look forward to working with Vyriad to explore this novel combination for patients with solid tumors.”

Avelumab has received accelerated approval** by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.

*Avelumab is under clinical investigation for treatment of various solid tumors and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for specific solid tumors by any health authority worldwide.

About Voyager-V1
Voyager-V1 (VSV-IFNβ-NIS) is derived from Vesicular Stomatitis Virus (VSV), a bullet-shaped, negativesense RNA virus with low human seroprevalence, specifically engineered to replicate selectively in and kill human cancer cells. Voyager-V1 encodes human IFNβ to boost antitumoral immune responses and increase tumor specificity, plus the thyroidal sodium iodide symporter NIS to allow imaging of virus spread. Three first-in-human Phase 1 clinical studies of Voyager-V1 are exploring intravenous and intratumoral routes of administration.

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PDL1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.1-3 Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.3-5 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and cocommercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including seven Phase III trials and nearly 8,300 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Indications in the U.S.**
The U.S. Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the U.S. FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S.
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S., enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immunooncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

About Vyriad
Vyriad is a clinical-stage biotechnology company developing novel oncolytic virus therapies for the treatment of cancers that have significant unmet need. Vyriad’s oncolytic immunovirotherapy product candidates are based on the company’s engineered Oncolytic Vesicular Stomatitis Virus (VSV) and Oncolytic Measles Virus platforms that enable selective destruction of cancer cells without harming normal tissues.

Vyriad’s product development pipeline encompasses multiple clinical- and preclinical-stage programs that target a broad range of cancer indications, as well as programs that pair the company’s oncolytic viruses with other cancer immunotherapy modalities, traditional cancer therapy, and newer targeted therapies. Vyriad’s lead program, Voyager-V1, is in Phase 1 clinical research in solid tumors and hematological indications (please see
clinicaltrials.gov). In addition, Vyriad is developing novel diagnostic/theranostic tests for more accurate prediction of immunovirotherapy response.

References
1. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control 2014;21(3):231-7.
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3. Boyerinas B, Jochems C, Fantini M et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res 2015;3(10):1148-57.
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Contact:
Titus Plattel
Chief Operating Officer
tplattel@vyriad.com

Genome Engineering Expert Says Minnesota Needs Big Money and Risk-Tolerant Attitude to become true Biotech Hub

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Genome engineering expert Dr. Perry Hackett was the guest of honor yesterday at the Byolincs “Meet the Expert” series. His mission: to examine ways to make Minnesota a world center for biomedical technology as a 21st century Silicon Valley.

Hackett built a strong career in genetic engineering, or techniques to specifically modify the genome, or all the genetic material, of an organism. Hackett spent a thirty-seven-year career at the University of Minnesota Twin Cities (UMN) and helped to found two biotech companies, Recombinetics and Discovery Genomics.

During his talk, Hackett laid out four key ingredients that he believes are necessary to make Minnesota a world-renowned hub for biotech: money, scientific talent and creativity, biotech leadership, and attitude.

Let’s start with the scientific talent.

“We are one of the world’s hubs for genome technologies and innovation,” Hackett explained.

Several groundbreaking genetic engineering technologies were developed in Minnesota, including the Sleeping Beauty Transposon system and Transcription Activator-like Effector Nucleases (TALENs).

The Sleeping Beauty Transposon system was created by Hackett himself in 1997. This system was integral to perform a technique called gene transfer, the long-term insertion of DNA into the genome of vertebrate cells. This technique can be used for gene therapy, or replacement of defective DNA with functional DNA to treat disease. The Sleeping Beauty Transposon System spurred Hackett’s first biotech startup, Discovery Genomics, in 2000, using the Sleeping Beauty system to treat blood diseases.

TALENs are enzymes, or specialized proteins, that precisely bind to and cut very specific DNA segments. These breaks in the DNA can be used to create defined mutations, or alterations to the DNA sequence. Alternatively, new DNA can be inserted in a highly specific manner between the cut sites. This technique, developed in part by UMN scientist Dan Voytas in 2010, completely revolutionized gene editing, allowing precision targeting of specific regions of DNA at levels “ten million fold higher” than ever before.

Voytas used this technology to launch his own biotech company Calyxt, a bioagriculture startup that genetically engineers healthier, more resistant food plants. Calyxt just issued an initial public offering (IPO) on July 20th, offering stock at $8/share. Less than two months later, the stock is now selling for $28/share.

Hackett’s own graduate student Scott Fahrenkrug used TALENs to also start a genome engineering company called Recombinetics, which Hackett says is a “Minnesota biotech story in the making.” Hackett is co-founder of the company.

Instead of genetically engineering plants, Recombinetics specifically edits the DNA of animals to create more robust, healthier livestock and generate highly specific animal models for pharmaceutical and medical device testing. The biotech firm largely works with pigs as a biomedical model, an animal that is a better mimic of human disease, lifespan, and organ size than mice and rats.

Minnesota arguably has the talent and scientific leadership to be a real biotech hub. What we’re lacking, Hackett said, is money and attitude.

Hackett explained that we need to foster a culture in Minnesota where “early failure is an option” and companies can make mistakes and not be penalized for them.

Hackett himself was told he was a failure for not having an IPO with Discovery Genomics. Some of Hackett’s first research at the UMN was to engineer faster growing Minnesota sports fish. After he successfully made the fish, the project was closed due to ecological concerns from releasing the fish into the lake systems.

“Our work was phrased as a biological Chernobyl that would extend from Minnesota to all the way down to New Orleans,” Hackett explained.

However, he said the team did not give up. This technology eventually led to the Sleeping Beauty system, the UMN Beckman Center for Transposon Research, the UMN Center for Genome Engineering, and Discovery Genomics.

Hackett said another piece missing from the Minnesota biotech ecosystem is big money from venture capital. Although the state was recently ranked as the thirteenth wealthiest city by Fortune, Hackett says that money is not making it into the state’s biotech startups. He explained that without local venture capitalists providing money, attracting outside capital, and bringing in validated leadership, Minnesota biotech companies will be forced to relocate to the funding sources.

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Byolincs is a group within Mayo Clinic dedicated to training and encouraging entrepreneurially minded scientists and medical professionals. The group holds their “Meet the Expert” series on the second Thursday of every month to learn from active bioscience entrepreneurs.

Two Minneapolis Biotech Startups Win Third Edition of Walleye Tank

The third installment of Walleye Tank, a Fishing Opener expedition, was held last Friday at the University of Minnesota-Twin Cities campus. Walleye Tank is a life science business pitch competition that celebrates the entire entrepreneurial community. The event took place in Minneapolis for the first time in the history of the competition. Twin Cities based startups Dolore Biotechnology and Dose Health walked away as divisional winners.

Walleye Tank occurs biannually in Minnesota. The pitch event originated at Mayo Clinic and has brought in competitors from Rochester and Minneapolis/Saint Paul since its inception. Walleye Tank contains two startup divisions: student “Junior Anglers” and more seasoned “Professionals.”

This edition, Junior Anglers featured student groups from both Mayo Clinic and the University of Minnesota- Twin Cities. The Mayo cohort developed the entire concepts for their pitches in the four weeks preceding the competition in an entrepreneurial class led by Dr. Ekker. The UMN student groups are under the guidance of Carla Pavone, Associate Director of the Gary S. Holmes Center for Entrepreneurship and Walleye Tank event planner.

In total, seventeen life science startups pitched their concepts to the “Walleyes”- a panel of seven biotech entrepreneurs, investors, and analyst experts- as well as to the gathered entrepreneurial community.

A group of three UMN student founders at Dolore Biotechnology won the Junior Angler division. Dolore Biotechnology is creating a portable, point-of-care device to provide rapid diagnosis for sickle cell disease from a single drop of blood.

Minneapolis startup RxFunction was runner up in the Professional Division. RxFunction developed a solution for peripheral neuropathy patients afflicted with balance problems called Walkasins. Walkasins consist of a leg unit and foot pad to measure foot pressure and provide immediate sensory input to users.

Minneapolis startup Dose Health walked away as the overall Professional Division winner. Dose Health created a smart pillbox to increase pill-taking compliance. Their device holds fourteen doses of pills in segmented compartments and sounds an alarm when it’s time to medicate. Multiple caregivers can be alerted if the pills are not dispensed.

For the first time in the history of the competition, Walleye Tank winners received entry as semifinalists in the Minnesota Cup, the state’s premier business pitch competition. Look for the next edition of Walleye Tank this fall.