How did OptiScan become the only company to gain US approval?-Peter Rule-12/12/2017 - 6:00pm

Event Information
Event Topic: 
How did OptiScan become the only company to gain US approval?
Event Date: 
12/12/2017 - 6:00pm
Event Location: 
Wilson Sonsini Goodrich & Rosati - 650 Page Mill Road, Palo Alto
Speaker Information
Event Speaker: 
Peter Rule
Event Speaker Title: 
Consultant to OptiScan (CEO from 2/06 to 10/17)
Event Speaker Company: 
Event Speaker Bio: 

Peter is a serial entrepreneur who has led five medical device startups (OptiScan BioMedical, PercuSurge, TheraSense, Ekos, MiniMed, etc.) financed by venture capital. Four of the five are profitable, thriving entities today. These four have been purchased. Most recently, BTG purchased Ekos Corporation for an announced valuation of approximately $220M (in July of 2013). The fifth company, OptiScan, is in "the mold" of the previous four: state of the art, large unmet medical need, cost-effective. Peter has been a part of all these companies from Series A, and driven them as late as profitability and cash flow positive. Characteristics of the companies Peter has been associated with are that they are excellent at clinical research, continuous product improvement, and have cohesive management teams. All have been state-of-the-art in terms of technology. All have, at times, required extensive efforts to finance, with a diverse set of investor groups and financial structures.

Event Details
$6 - Students/In-transition - Members only
$11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members
$25 - Walk-ins
Event Details: 

At one time, approximately 25 companies totaling well in excess of $1B in funding, attempted to create or modify an existing product to achieve US approval for an ICU continuous glucose monitor. Only one company succeeded. There are 3 reasons for this: first, fitting the end product to the needs of the customer. These included the need to invent a fluidics system to extract a tiny amount of blood, heparinize the blood away from the patient, but not deliver heparin to the patient, centrifuge the sample to create plasma, and invent a new means to measure glucose, which does not require calibration.
The second reason was the commitment to clinical research, where the company learned in 2 EU single-center trials and one final US multi-center trial, about its product, and needed improvements. As well, the company obtained reliability data by launching in a single country in the EU. Prior to submission, the company called an independent Clinical Advisory Board to review the trial’s aggregate and patient by patient data to create a Benefit v. Risk assessment.
Finally, the amount of money raised to date was over $150M.