Medistim

Regulatory Filings • Jun 1, 2015

Medistim is sponsoring REQUEST, a multicenter registry study with leading hospitals from Europe, USA and Canada

Medistim is sponsoring REQUEST, a multicenter registry study with leading hospitals from Europe, USA and Canada

(Oslo, June 1st 2015) Medistim ASA (OSE: MEDI), a

medtech company that develops and distributes

surgical guidance and quality assessment devices,

announces the 1 million Euro sponsorship of REQUEST

(1). This prospective, multicenter, registry study

of about 1,000 patients will provide new data on how

the use of Medistim's devices for flow measurement

and intraoperative imaging can be employed to

optimize decision making during coronary artery

bypass grafting (CABG) and become routine clinical

practice.

As many countries are going through reforms to make

quality healthcare available to a growing population

in a financially sustainable way, demands are

increasing to reduce errors and re-interventions.

In the USA, the Affordable Care Act ('Obamacare') is

driving initiatives to improve the quality of care

during hospital inpatient stays. From 2017, the

Centers for Medicare and Medicaid Services will

start cutting reimbursement for 30-days readmission

after CABG. Consequently, hospitals need to not

only deliver, but also document, high quality

surgical results.

In CABG, the implementation of technology to provide

intraoperative surgical guidance and quality

assessment provides one potentially impactful way of

achieving and documenting improved quality and

outcomes. The hypothesis motivating the REQUEST

registry study is that employing a new and unique

combination of functional flow measurement and

morphological ultrasound imaging data will enable

surgeons to make better informed decisions during

coronary surgery, and thereby improve surgical

quality, outcomes and ultimately, contribute to

improved healthcare efficiency from this surgical

procedure.

It is anticipated that about 1,000 patients will be

enrolled in the registry over the next 18-24

months. The interest amongst hospitals in joining

the REQUEST registry study has been very

encouraging, and the participants represent some of

the most advanced heart programs in the world:

- Erasmus MC, Rotterdam, NL / Coordinating

Investigator Prof. A. P. Kappetein

- University of Oxford, UK / Principal

Investigator Prof. David Taggart

- University of Essen, GER / Principal

Investigator Prof. Heinz Jacob

- University G D'Annunzio-Chieti, IT /

Principal Investigator Prof. Gabriele Di Giammarco

- Mount Sinai Beth Israel, New York, USA /

Principal Investigator Prof. John D. Puskas

- George Washington University, VA MC,

Washington DC, USA / Principal Investigator Prof.

Gregory D. Trachiotis

- University of Calgary, CAN / Principal

Investigator Dr. Teresa Kieser

To lead the REQUEST registry study initiative,

Professor A. Pieter Kappetein from the Erasmus

Medical Centre in Rotterdam, has accepted the role

as Coordinating Investigator. Professor Kappetein

is highly regarded amongst his colleagues as one of

the thought leaders in the field. He has extensive

experience from some of the most influential

clinical trials from the past decade and is holding

key roles within both European and US surgical

associations.

"From the patients' perspective, they undergo CABG

not only to extend their lives, but to have a high

quality of life, free of recurrent angina, repeated

cardiac catheterizations and potential percutaneous

interventions or redo CABG. Surgeons who are

performing this complex operation continue to

explore how the quality and outcomes of coronary

bypass surgery could be further advanced," says

Professor A. Pieter Kappetein, Coordinating

Investigator of the REQUEST study. "Clinical trials

like the SYNTAX(2) trial have shown the long-term

superiority of CABG over alternative, percutaneous

coronary interventions in multi-vessel disease. It

is critical to the patients and our duty as

surgeons, to continue to develop the procedure in

order to bring down the risk of adverse events as

far as possible. I strongly believe that the REQUEST

study is an important initiative that may provide

new insights that could positively impact clinical

outcomes and change clinical practice going forward."

Medistim's interest in sponsoring the REQUEST study

with about 1 million Euro over a two-year period is

consistent with the company's many years of close

collaboration with heart surgeons worldwide and a

continued commitment to help advance medicine in

this field. "A study like REQUEST is pivotal to

increase the interest, awareness and acceptance for

the needs for and importance of adopting new and

innovative technologies to improve decision making

and thereby surgical quality and outcomes," says

Medistim President and CEO, Kari E. Krogstad. "At

the end of the study, we hope to establish a

consensus for a recommended workflow to optimize

decision making during CABG, and hopefully, gain

guideline endorsements for such use of flow

measurement and imaging data, in the USA as well as

other countries."

1) REgistry for QUality assESsmenT with Ultrasound

Imaging and TTFM in Cardiac Bypass Surgery

2)N Engl J Med 2009; 360:961-972March 5, 2009

For more information, contact:

President and CEO, Kari E. Krogstad, Medistim ASA

Tel: + 47 918 38 110

E-mail: kari.krogstad@medistim.com

CFO, Thomas Jakobsen, Medistim ASA

Tel: + 47 906 59 940

E-mail: thomas.jakobsen@medistim.com

About CABG and the use of TTFM and intra-operative

imaging:

30 days mortality after CABG is about 1.9% and

stroke-rate 1.2%. Medicare data analysis suggests

that more than 3% of patients undergoing CABG will

receive re-intervention with PCI (angioplasty,

stents or atherectomy) during the first 3 months

post surgery and more than 5% during the first

year.

While TTFM (transit time flow measurement) for graft

patency assessment today is accepted as standard of

care in most European countries and Japan, it is not

yet routinely used in the USA, the UK, France or the

Netherlands. TTFM is endorsed by the European

guidelines and UK's NICE, still, the vast majority,

about 75% of CABG procedures performed globally

every year are done without TTFM or intraoperative

guidance technology.

TTFM is supported by several retrospective cohort

studies showing the clinical benefits. Recently,

high frequency epiaortic ultrasound has been

introduced as a method to allow for intraoperative

surgical guidance and quality assessment during

CABG. The use of aorta scanning is well documented

and endorsed by US guidelines, while imaging of

native vessels, grafts and the anastomosis, has been

reported as clinically beneficial in some clinical

reports.

About Medistim

Medistim was established in 1984, and has a track

record of profitable growth over the past >10

years. The company is a pioneer within its segment,

and continues to invest in new product development.

Medistim has wholly owned subsidiaries with sales

organizations in the USA, Germany, UK, Denmark and

Norway, in addition to about 50 distributors in

Europe, Asia, Middle East, Africa and South

America.

For more information, visit the Medistim home page:

www.medistim.com

This information is disclosed under Norwegian law

(Verdipapirhandelloven §5-12).