Global Kinetics Corporation’s PKG® Smartwatch Provides Clinically Meaningful Improvement in Parkinson’s Disease Symptom Assessment, Management and Medication Optimization, As Well As Projected Per Patient Cost Savings
The year may be racing for the finish line, but Medical Alley early- and growth-stage companies won’t be eager to see it end. The first half of the year put 2018 close to the pace set by the record-breaking 2017 and the third quarter didn’t break stride. Companies based in Medical Alley raised $176,089,457 in Q3, the second best Q3 in the last five years, and keeping the region on pace to break a half-billion dollars in total money raised in 2018.
Biotech and digital health continued their strong years, but perhaps the most interesting insight that can be pulled from the data is that medical device – which had swooned a bit – seems to have returned to the forefront of investors’ minds.
Q3 Breakdown: From Strength to Strength
Q3 saw $176 million raised by 27 companies and the year-to-date reached $416M raised by 64 companies. While Q3 is down from a year ago, that is due in large part to fewer post-IPO raises in the quarter than there were in 2017. Removing those post-IPO numbers shows continuing strength in fundraising.
2017 had Bright Health’s massive raise of $160 million, an all-time Minnesota record. Comparing 2018 to 2017 without Bright Health shows the community’s great foundation and an expanding pool of Series A/B-type investments.
Device Investment Returns to Industry Capital, Medical Alley
Though the Medical Alley region has come to be known for its contributions across the healthcare spectrum, but there’s little doubt that medical device companies were integral in establishing the region as a healthcare hub. After decades of strong growth, the 2000’s dot-com bubble ushered in a lost decade for investment in technology, including medical devices, in Minnesota. Fortunately, investment in healthcare broadly has been on the rise since 2009, a trend that looks set to continue in 2018.
In the Q3 of 2018, Medical Alley device companies raised $90 million, pushing the total for the year to nearly $200 million raised by 33 companies. Q3’s largest raises in device included Urotronic ($26 million), 4C Medical ($17 million), and Cardialen ($17 million).
2017 was an especially strong year with multiple growth capital rounds raised in excess of $20 million. Looking over the five-year period from 2014 to 2018, nearly $1.5 billion has been raised by 118 device firms, $300 million more than the 2009-2013 period. With a quarter to go, the gap is likely to widen even more. Venture investing can be highly volatile quarter-to-quarter and thus we take greater interest in examining total investment over five- and ten-year periods to correspond with the lifecycles of many investment funds.
The $1.6 billion in device investment raised in the last five full years (2013-2017) makes Medical Alley not only the top region for medical device investment in the Midwest, but the top region for all healthcare investment in the Midwest, surpassing Ohio and Illinois by hundreds of millions of dollars.
Biotech Sets New Milestone in Medical Alley
Biotech continues its impressive run, breaking $100 million in capital raised in a year for the first time in Medical Alley history. $104 million has been raised through three quarters by 14 companies. Recombinetics had the largest Q3 raise with $34 million led by Gundersen Health System. This comes on the heels of a $7 million raise earlier this year, bringing their annual total to $41 million.
Recombinetics’ gene editing technology is making waves in the media, including coverage for their recent partnership with Medical Alley Association Foundational Member Mayo Clinic to grow human heart cells for eventual transplantation. They join fellow MAA member Miromatrix in leading the way toward a reduced need for long transplant waiting lists.
Drawing on the leadership of the University of Minnesota and Mayo Clinic, Medical Alley has a long history in biotechnology and pharmaceuticals. Leadership from companies like Upsher-Smith LLC, Bio-Techne and Be the Match is increasingly augmented by startups like Recombinetics, Stemonix, and Vyriad.
Digital Health Cements Position in Medical Alley
Digital Health investment continued its strong run with $32 million raised in the third quarter for a year-to-date total of $116 million. Taking into account the lower startup capital requirements compared to device or biotech, the quarter’s $32 million raise is a strong number.
Praestan Health ($12 million) and Learn to Live ($6.5 million) had large raises and represent a growing trend of investment in mental and behavioral health; in fact, no digital health company in Medical Alley bested Praestan’s $12 million raise. Medical Alley companies are making significant strides to eliminate the stigma around mental health and to create effective, novel solutions for mental illnesses.
Sansoro Health ($8 million) had the other major raise for the quarter. The demand for interoperability is driving solutions like Sansoro’s to the forefront of health innovation.
All Major Sectors in Medical Alley Break $100 million Raised for First Time
All three major sectors of the Medical Alley health innovation cluster broke $100 million in funding for the first time. Diversity is becoming a major strength of the cluster, insulating Medical Alley from the ups and downs of the finance world, and making it easier to attract top talent to the region. While historically Medical Alley was dependent on one sector – medical device, especially implantable and interventional devices – increasingly digital health and biotech are raising major growth rounds, seed rounds and everything in between.
With a balanced regional portfolio of growing companies, a year of strong exits, and still a quarter to go, Medical Alley is positioned to grow its leadership as the global epicenter of health innovation and care.
Investment in Medical Alley has doubled over the last five years, reaching more than $700 million in 2017. The state’s share of total venture capital investment increased from 28th in 2016 to 15th in 2017.
What is driving this increase? Here are four trends that help explain the increase:
Known for leadership in medical devices, Medical Alley is also leading in other aspects of healthcare innovation.
Innovative startups like Bright Health and Zipnosis are pioneering new models of care, and established firms like UnitedHealth Group and Blue Cross and Blue Shield of Minnesota are backing dozens of firms working to disrupt the status quo in healthcare.
Personalized medicine is a reality through companies like OneOme, Recombinetics, and Stemonix. Research from Mayo Clinic and the University of Minnesota is making cures once thought impossible a reality.
Medical Alley’s diversity has positioned the ecosystem to address the breadth of complex issues with novel solutions. In the first quarter of 2018 30 percent of the companies raising money were digital health, 23 percent were biopharma, and 47 percent were medical device.
Rochester, Minnesota, the home of the #1 hospital in the US, Mayo Clinic, is an emerging hotbed of healthcare startups. Drawing on world-leading clinicians, companies are rapidly finding their product-market fit.
A recent report from Chartio’s Tim Miller found that growth in Plymouth, Minnetonka, and Rochester is driving Minnesota’s improvement in venture capital market share.
In the past, much of the innovation developed by the Mayo Clinic ended up outside of Rochester, but recent efforts have turned this around, with more innovations incubating right in the clinic’s backyard. The work of Mayo Clinic Ventures, Collider, and the BioBusiness Center has made this transformation possible.
Industry leaders have observed that the dearth of exits has held back growth nationwide. But from 2012 to 2016 Minnesota led Midwestern exit productivity with 44 exits. 2017 saw exits for Upsher-Smith, Entellus Medical and three others that generated almost . 2018 has seen a pair of exits already, ABILITY Networks and NxThera, which returned $1.6 billion to investors. A third, Inspire Medical Systems’ IPO, is in the works.
Healthy returns are proof of the vitality of the Medical Alley community; refilling the coffers of investors will set the stage for continued success.
A dollar is a dollar anywhere in the US, but in Medical Alley, it gets you more. Ping Yeh, CEO of biotech startup, Stemonix, said it in the March issue of Site Selection “A million dollars here is going to last at least six times [longer than] it would in parts of California.” Capital efficiency means you need less to start, less to continue, and less to generate ROI. Lower cost of rent, consulting, and other inputs reduces the amount of capital needed.
Affordability is not the only driver of efficiency in Medical Alley, in fact the biggest drivers may be domain expertise and strong networks. Expertise in clinical trials and regulatory affairs results in PMAs approved 6 months faster than anywhere else. Strong business networks mean finding an advisor or consultant is a snap. These efficiencies stack, accelerating time-to-market and lowering capital expenditure.
No one would deny that starting a company, raising capital, and building to an exit is hard. It may even be harder today than in the past. But the data coming out about Medical Alley is clear: entrepreneurs here are finding solutions to the biggest healthcare problems and to the challenges of starting and growing a company.
Want to know more about Medical Alley’s leadership in healthcare innovation? Visit https://www.medicalalley.org/
The Minnesota legislature is on ‘spring break’ this week following two intense weeks of committee hearings. Last Thursday (March 29) was the second committee deadline – so unless a bill has made it through all necessary committees, it will meet one of three fates: dead for the year, receive a special exemption from deadlines (very rare), or be included in an omnibus finance bill.
Below is a quick update on several of the bills Medical Alley Association is tracking this year. If a bill you are interested in is not discussed, please let our Government Relations team know and they will get you an update.
Summary: The Angel Investment Tax Credit provides qualified investors in certified small businesses with a refundable income tax credit equal to 25 percent of their investments up to a maximum of $125,000 ($250,000 for married joint filers).
There is currently no funding for tax credits through this program. These bills fund this program beginning for tax year 2018 – while the amount of available tax credits differs in the bills ($20 million/annually in HF89; $5 million/annually in SF1668). Each bill also removes the sunset on the program, eliminating the need to reauthorize the tax credits.
Current Status: The Angel Investment Tax Credit was heard in the House Tax committee last year and Senate Tax Committee on March 29, 2018—receiving overwhelming support. The bill was laid over for possible inclusion in the Senate omnibus tax bill.
What’s Next: HF89/SF1668 were included in both the House and Senate Tax bills last year but fell out in conference committee. This year, Governor Dayton included funding for the Angel Tax Investment Credit in his supplemental budget proposal ($10 million for 2019 only). When meeting with legislators we have heard little opposition to the program and are working hard to get funding included in each chamber’s tax bill again this year. These bills are expected to be released shortly after the legislative recess concludes, so look for an update soon.
Summary: This bill establishes the Opioid Addiction Prevention and Treatment Advisory Council. This council will review state opioid policy and make recommendations to the commissioner of human services on the provision of grants and funding to address opioid addiction. The bill also establishes the opioid addiction prevention and treatment account as a special revenue fund. This special account is funded through a new tax on opioids.
There are significant differences between the House and Senate bills that are touched on below.
Current Status: SF730 contains the new tax on every opioid pill sold in Minnesota and a new registration fee & surcharge on opioid manufacturers. HF1440 originally featured this tax as well, but it was removed from the bill in committee.
SF730 was heard in the Senate Finance committee on March 28th. There was no public testimony, as public testimony was taken in earlier hearings. Senator Rosen walked through the fiscal impacts of the amendment and members offered comments. While there is bipartisan support for the bill, the senators do not believe that the State should have to cover the cost of the epidemic.
HF1440 also originally established put a tax on opioids as well. With no foreseeable agreement on this issue in the House, however, Rep. Baker turned to other options – primarily the state general fund – to help fund the bill’s proposals for addressing the epidemic.
Rep. Baker also added an amendment regarding the Prescription Monitoring Program (PMP). This assures no new requirements or procedures are set in place for those who currently have access to the database. It does not require a prescriber to access the database prior to issuing a prescription for a controlled substance. This raised concern with some who believe that prescribers should be mandated to look in order to get a handle on the epidemic, which some believe is partially due to overprescribing.
What’s Next: SF730 was laid on the table in the Senate Finance committee. Sen. Rosen said discussions need to take place between her and PhRMA before moving forward on this bill in the Senate.
HF1440 was referred to the Health and Human Services Finance Committee, where it will be heard on Tuesday, April 10. The bill could either receive a deadline waiver to move forward on its own, or be laid over for possible inclusion in an omnibus budget bill.
Summary: The bill creates a council to get information to families who have a member with a rare disease about available treatment, coverages, and information generally about the disease. Most voting members are appointed by the Board of Regents with four members of the legislature making up the remainder. Ex officio members include the commissioner of health, a representative of the Mayo Medical School, and a representative of the University of Minnesota Medical School.
Current Status: The bill was heard in both the House and Senate last week with wide bipartisan support. A delete everything amendment was adopted which refines how the council will work. The amendment gives the U of M oversight of the council, as they have the resources and ability to administer the council.
Creation of this council will help bridge the gap in knowledge of doctors for rare diseases. The University of Minnesota has the opportunity to lead the country and world in finding treatments and cures for rare diseases.
What’s Next: The House heard the Rare Disease bill in Health and Human Services Reform, Government Operations, and Higher Ed and Career Readiness Policy and Finance committee. The bill was referred to the committee on Health and Human Services Finance committee and is scheduled to be heard on Tuesday, April 10th, where it will likely be laid over for possible inclusion in an omnibus budget bill.
The Senate companion, SF2786, was heard in the Health and Human Services Finance and Policy committee as well as State Government Finance and Policy and Elections on March 29th. The bill was referred to the committee on Higher Education. If passed, it will likely be sent back to the Health and Human Services Finance and Policy committee. From there its best past forward is being included in an omnibus budget bill.
Summary: Provides that a contract between an employer-sponsored health plan or health plan company, or its pharmacy benefit manager, and a licensed pharmacy, may not prohibit a pharmacist from informing a patient when the amount the patient would pay for a particular drug under the patient’s health plan is greater than the amount the patient would pay out-of-pocket at the pharmacy’s usual and customary price.
Current Status: This bill has bipartisan support in the House and Senate.
The House added an amendment to HF3024 that defines allowable cost as what the lowest cost would be if consumer did not purchase through health care plan
What’s Next: The House heard the bill in the Health and Human Services Finance Committee on March 28th, and sent it to the General Register. In the Senate, the bill was laid over and may become part of an omnibus budget bill.
Summary: Step therapy is a policy requiring a patient to try and fail first on several medications before receiving their doctor-prescribed medication. This bill improves the one size fits all approach. It creates a waiver process to override the step therapy protocol if the provider believes patient needs access to a specific medication.
For an override to be granted the enrollee must meet one of the following:
If step therapy may cause physical or mental harm to patient; or
The prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen; or
If the patient is stable on medication and provider can prove that the patient can stay on that medication
Current Status: The bills were heard both in the House and Senate last week to meet the second committee deadline. Throughout the committee process considerable time was spent between authors and stakeholders to address concerns with the bill. These efforts helped obtain bi-partisan support in both bodies.
What’s Next: The Senate companion was passed out of Health and Human Services Finance Committee on March 27th and sent to the Finance committee where it awaits a hearing.
The House State Government Finance committee passed the bill Thursday Night, March 29th, 2018 and referred it to the Health and Human Services Finance committee. Unless it receives a deadline waiver in the House, this bill will have to be part of an omnibus budget bill to get completed this year.
Summary: This bill modifies patient consent requirements under the Minnesota Health Records Act for the release of health records. It would align Minnesota’s procedures with what is currently required under HIPAA.
Current Status: This bill was heard in the House Health and Human Services Reform committee on March 5, 2018 where it was passed to the Civil Law and Data Practices committee. It did not receive a hearing in this committee before deadline.
The Senate companion did not receive a hearing in the Senate.
What’s Next: Without a deadline waiver in each body, this bill cannot move forward this year, unless it is included as part of an omnibus budget bill.
Summary: This bill establishes a Minnesota Health Policy Commission to develop recommendations for steps to take to improve health care and health outcomes at lower cost. This Commission would be comprised of independent experts in health care finance, health economics, actuarial science, health plan management and finance, health care system management, purchaser and an expert in development and utilization of innovative medical technologies, a health care consumer advocate, a primary care physician, a long term care provider and someone with direct experience as an enrollee, or a parent or caregiver of an enrollee in MinnesotaCare or medical assistance.
Current Status: Advocates support the establishment of the Commission because data shows Minnesota has some of the highest commercial health care costs in the country, and this Commission will help find ways to reduce those.
Those who have addressed concerns with the bill believe someone with a background in Mental Health should be appointed to the commission, and that the commission is heavily skewed towards the industry and less on the patients. Others have pointed out that several items in the bill are being addressed by agencies and non-partisan staff.
The bill authors have been receptive to the concerns raised by advocates, those with concerns, and members of the legislature. They continue to work with all involved to modify the bill so it can continue to move forward.
What’s Next: The House passed the bill out of Health and Human Services Reform committee on March 27th and State Government Finance Committee on March 29th. It was referred to the Health and Human Services Finance committee. They have scheduled to hear the bill on Wednesday, April 11th. The bill is likely to be laid over for possible inclusion in an omnibus budget bill
The companion bill in the Senate was heard in State Government Finance and Policy and Elections and Health and Human Services Finance and Policy committee. It was referred to the Judiciary and Public Safety Finance and Policy committee where it awaits a hearing. This bill will either be laid over for possible inclusion in an omnibus budget bill or referred back to the Health and Human Services Finance and Policy committee, where it also likely be laid over for possible inclusion in an omnibus budget bill.
Summary: This bill proposes a constitutional amendment allocating state general sales tax revenue related to motor vehicle repair and replacement parts exclusively to fund roads. This amendment would be on the ballot in 2018 for voter approval.
Current Status: The bill was heard in the Senate Transportation Finance and Policy Committee on March 28th. There were several testifiers—those supportive of the bill believe we need to dedicate stable funding to take care of our infrastructure and jobs. Those opposed believe the constitutional amendment would put roads and bridges over health care and trade unions over education.
The bill as amended would:
What’s Next: The bill passed on a party line vote and was referred to the Rules committee. There is no companion in the House. If a bill is introduced, and given a hearing the Transportation Finance Committee. To advance any further it would need to receive a deadline waiver and also pass the Rules committee before advancing to the General Register.
There are only six weeks remaining in the 2018 Minnesota Legislative Session – but there is quite a bit of work still on the docket. This work includes negotiating and passing bills to conform Minnesota’s tax code to changes at the federal level, a capital investment bill that would bond for millions of dollars in new public projects and a supplemental budget bill. The legislature likely will also pass legislation addressing the opioid epidemic in Minnesota, improving school safety, and more solutions for the troubled MNLARS system.
The upcoming 2018 elections continue to be at the forefront of everyone’s mind at the Capitol. Election considerations have a heavy influence on almost every major policy decision being made. The entire House of Representatives is up for re-election (currently controlled by Republicans 77-57), as is the Governor’s office. Neither Republicans nor Democrats know who their candidate will be – but both parties will use the last few weeks of the legislative session to lay out their overall message to voters.
Further, since Governor Dayton is not on the ballot this fall, election considerations are not as important to him as in the past. This could result in additional deal-making with Republican legislators – or in the Governor taking a harder stance against proposals he does not agree with. Governor Dayton has said on several occasions that he wants to leave the state on solid financial footing, so look for this to play a major factor in negotiations down the stretch.
Our Government Relations team is on the ground every day at the Minnesota State Capitol, tracking and advocating for issues important to Medical Alley Association’s members. Look for more updates and inside information about the conclusion to the legislative session in coming weeks.
On Wednesday, March 28, the Senate Taxes committee held a hearing on SF1668. This bill, authored by Senator Paul Anderson, would make the Angel Investment Tax Credit permanent and fund it at $5 million annually. Two Medical Alley Association members were there to testify in support of the legislation – Paul Hines from DOSE Health and Michael Lacey from Prevent Biometrics. Each of them testified how the Angel Investment Tax Credit helped attract investors early on, enabling each company to grow and draw additional investment. The committee members were supportive and the bill was laid over for possible inclusion in an omnibus tax bill. Medical Alley’s success is about the success of our members. Legislators need to hear from you. Please share your stories, successes and challenges with us. If you are interested in taking an active role in our efforts, meeting with legislators or testifying on issues, please let us know. Our Government Relations team will do all the work!
The House Agriculture Finance committee met on Thursday, March 29, to hear about Minnesota’s preparedness for foreign animal diseases outbreaks. Medical Alley Association member Recombinetics testified about how their gene editing technology can be used to help prevent certain future disease outbreaks. Thanks to Mitch Abrahamsen, Chief Commercial & Scientific Officer, at Recombinetics for coming and sharing the great work being done by an innovative Minnesota company.
First committee deadline week is usually one of the busiest weeks all year at the Minnesota Capitol – and this year was no exception. Policy committees in both the House & Senate heard dozens of bills every day. Some bills received hearings on back-to-back days in different committees.
Several bills being tracked by Medical Alley Association received hearings last week. These include bills to limit prescriptions of opioids for acute pain to seven days (SF3323 – Benson); to provide for an override of step therapy protocols in certain situations (HF3196 – Fenton); and to fund prevention & treatment programs to help with the opioid epidemic (HF1440 – Baker) (Note: The companion bill, SF730 – Rosen, contains the new tax on every opioid pill sold in Minnesota and a new registration fee & surcharge on opioid manufacturers. HF1440 originally featured this tax as well, but it was removed from the bill in a House committee two weeks ago.)
We were fortunate this week to have two Medical Alley Association members in St. Paul to meet with legislators on the 2018 Health Technology Economy Agenda. A big thank you to Patrick Yoder & Tim Morin from LogicStream Health and Kris Huson from Recombinetics!
Medical Alley’s success is about the success of our members. Legislators need to hear from you. Please share your stories, successes and challenges with us. If you are interested in taking an active role in our efforts, meeting with legislators or testifying on issues, please let us know. Our Government Relations team will do all the work!
This week will again be a very busy week in committee, as the second committee deadline is Thursday evening. A few of the bills Medical Alley Association is supporting will receive hearings this week.
The Senate Taxes committee will be hearing a bill funding the Angel Investment Tax Credit on Wednesday. Medical Alley Association will be there to testify in support of the bill. Reinstating the Angel Investment Tax Credit is the top legislative priority for Medical Alley Association this year. This bill will likely be held for possible inclusion in the Senate Taxes Omnibus bill and will not be passed out on its own (this is the typical process for tax bills).
The House heard this bill last year and does not need to hear it again this year to include it in the House Taxes Omnibus bill.
The Senate Health & Human Services Finance and Policy committee, on Tuesday, will hear legislation providing for an override of step therapy protocols when certain criteria are met. Medical Alley Association is part of the coalition advocating for the passage of this bill. This bill likely will have at least one more committee hearing this week, should it pass out of Senate HHS Finance & Policy.
The House companion (HF3196 – Fenton) passed through two committees in the House last week and is awaiting a hearing in the House State Government Finance committee. If granted a hearing here, it would have one more committee stop to make before deadline on Thursday night.
This bill will likely see multiple committee stops in the House & Senate this week. Right now it is scheduled in Senate HHS Finance & Policy, House Higher Education Policy & Finance on Tuesday. It will require stops in at least Senate State Government & Elections Finance and House HHS Finance before the deadline on Thursday night.
The language in the House & Senate differ slightly, but generally this bill would create a council to advise on research, treatment, and education related to rare diseases.
The Senate Finance committee will take up Senator Rosen’s bill (SF730) to create a new tax on opioid prescriptions, a new registration fee & surcharge on opioid manufacturers, and set a seven-day limit on the prescription of opioids.
Medical Alley Association has a number of concerns with this bill. These include the creation of an extensive tracking system and reporting responsibilities for manufacturers; lack of clarity on impact to non-opioid pain management solutions; and significant cost increases to healthcare systems and patients through a new tax on opioids sold in Minnesota, in addition to concerns over implementing a new tax when other funding mechanisms are available. We are working with the author to address these concerns.
This bill is likely to be slightly amended and passed out of committee to the Senate Floor, where it will await a vote of the full Senate.
We are continuing to track many other pieces of legislation including several relating to opioids. Look for a full update on where all the bills MAA is monitoring stand, following the first two committee deadlines, next week.
On Friday afternoon Medical Alley Association member Teleflex hosted Congressman Paulsen at their Maple Grove facility. He toured the facility, met with Teleflex employees, and talked with them about how the Medical Device Excise Tax impacts them. Congressman Paulsen has worked tirelessly to fully repeal this tax and was instrumental in securing its current two-year suspension.
Also on Friday, several Minneapolis-based Medical Alley Association members met with Minneapolis Mayor Jacob Frey. They discussed several issues including the need to continue attracting top talent to Minnesota and how Minneapolis plays a big role in doing this. Thank you to Mayor Frey for meeting with us and we look forward to continue working him on strengthening Medical Alley as the Global Epicenter of Health Innovation and Care.