Medical Device Market Access Solution

Fostering Patient and Physician Access to Innovative Therapies in Japan

 

 

Interview posted: April 14, 2020



ARC Institution was established in Tokyo by CBS ’96 alumnus Mike Van Zandt several years ago. ARC’s original mission was to assist US medical device companies with access to the Japanese healthcare market with a focus on interventional cardiology products. In doing so, many opportunities presented themselves to provide M&A advisory services, strategic alliance facilitations and licensing deals with US firms located in many of the US device hot-spots, mainly in Silicon Valley.

CBSACNY: What’s the Tokyo - Silicon Valley connection?
An early ARC core client was Trireme Medical, a Pleasanton, CA based company. Ultimately, the founder, Eitan Konstantino, created a holding company over TriReme called QT Vascular and listed on the Singapore Exchange. The two of us founders became quite close when working on marrying a Japanese drug with the TriReme Chocolate Touch peripheral vascular drug-coated balloon (DCB) catheter. I jokingly say he fired me as his advisor and hired me as the global president of the TriReme Peripheral Vascular Division.

CBSACNY: Any connection to NYC these days?
Yes, of course! Columbia Presbyterian is one of our major clinical trial sites for the Chocolate Touch Investigational Device Exemption (CTIDE) study, of which, we are 90% enrolled. Additionally, we work closely with Syntactx, a clinical research organization (CRO) based in lower Manhattan. Incidentally, the Syntactyx Founder, President & CEO, Dr. Kenneth Ouriel, is also a Columbia MBA!

CBSACNY: How is your product differentiated?
The Chocolate Touch, unlike other DCBs, employs a nitinol constraining system encapsulating the angioplasty balloon that gently restrains the balloon during inflation. This creates a series of “pillows” that minimizes trauma when plaque is pushed against the walls when opening the artery. The underlying platform, employing the same principles, but without a drug coating was acquired by Medtronic and is commercially available worldwide.

CBSACNY: What are some of your achievements to date?
We basically act as an incubator with four major assets. We were able to take the company public in the Singapore exchange in 2014 due to their clinical viability. Two of those assets were sold to Teleflex (TFX) for approximately $100M and one sold to Medtronic (MDT) in this 2018 deal. We are quite proud of these asset sales as TFX and MDT, the largest pure-play medical device company, as they have extremely high product performance requirements and some of the best quality systems in the world, showing our commitment to quality and performance.

CBSACNY: How well are you funded?
We are pretty well-funded via our own sales for our current FDA clinical trial in which we are engaged (CTIDE). We have funded this trial via our own revenue of about USD $19M. We are in a raise for $10M to complete our current above-the-knee (ATK) trial and looking for an additional $7M to begin and complete a below-the-knee (BTK) clinical trial. We are randomized against the Becton Dickinson (BDX) Lutonix product and it is the first DCB to include atherectomy in the study protocol. Bard (BCR) acquired Lutonix for $325M. BCR, in turn, was acquired by BDX for $24B.


If alumni know of potential medical device investors, please reach out to Mike Van Zandt: MVZ@TriRemeMedical.com, MVZ@Arcinstitution.com.


Abbreviated bios of the founders:

Eitan Konstantino
Founder/Group CEO - TriReme Medical, QT Vascular, AngioScore, Advanced StentTechnologies
Inventions and patents have generated approx. $800M in global cumulative revenue
Technion University
BSc, '94; MSc '96, PhD '99


Michael D. Van Zandt

President - TriReme Medical Peripheral Division 
former CEO, USCI Japan/USCI Ireland
VP/GM, Boston Scientific Japan Cardiology
VP Asia Pacific, Middle East & Africa, Boston Scientific Cardiology
Director, Medtronic Marketing

Colorado College
BA '92
Columbia Business School
MBA ’96