The Acronym edition: JPM, CES, MAE, FDA...
We got something for that below. But first...
I heard from a few of you on the last newsletter that I hated holidays.
Big fan of 4th of July!
Southern folk luv blowin’ stuff up and will spend lots of folding money to do it (>1B$).
So my son Jack is 15 years old now, but I recall an idea he had when he was around 8.
He had this GREAT idea to make money: Businesses could gain more customers if they just gave away their stuff for free.
I got really mad at him—knee jerk. Parental habit, but I wanted to throw the business canvas at him and preach value propositions, but maybe he had a point.
Last year, Proxima gave away several free regulatory strategies as part of contests and in support of MedTech Innovator who we are partnering with again this year. We’re a big fan of these guys, btw. Extended deadline to apply by Feb 1! We’re gonna give some more stuff away, too, but back to the contests.
The client meetings were sometimes awkward. Maybe it was just me?
People like free stuff. But we’re VERY skeptical when we get it.
Maybe I’m not doing it right. What are your best marketing ideas (or your worst)? @ProximaCRO.
This year, rather than some hokey contest, we just decided to show folks the money. We’ve made a lot of progress over the last two years with building and curating an investor network, and now we want to share the wealth (you had to see that one coming). If you’re over your JP Morgan hangover, share your pitch deck on our website and we’ll see what we can do.
Also—take note, investors. We got stuff for youse, too!
Reclassification of medical cranial electrical stimulation (CES) has been going on for years.
The pharma lobby is strong with this one.
Now finally a new opinion. Reclassification of CES Medical devices.
Forward this newsletter to anyone that may need some splainin’.
Screen those expense reports before you sell your company!
On December 18, 2019, the Delaware Chancery Court issued a loonnngggg opinion regarding Channel Medsystems, Inc. v. Boston Scientific Corporation. Essentially, the ruling is that buyers (strategics) claiming a Material Adverse Event (MAE) face a heavy burden to “change their mind” once they’ve committed to the decision.
Boston Scientific entered into a merger agreement to acquire Channel Medsystems, a private medical device company that had one product, for up to $275 million. Under the merger agreement, Boston Scientific was only required to close the transaction if the FDA approved the target company's sole product by September 2019.
The conflict arose after Channel discovered that it's Vice President of Quality had falsified various expense reports and other documents in a scheme by which he stole approximately $2.6 million from the company over the course of five years. Some of the falsified documents were included in the company's submissions seeking FDA approval. (If you’re like me, you’re wondering who has 2.6M in expenses, but I digress).
Boston Scientific terminated the agreement, claiming fraudulent inducement and maintaining that Channel breached several representations in the merger agreement.
Channel filed suit for specific performance (do what you said you’d do) of the merger agreement. The FDA ultimately approved Channel’s product in March 2019, consistent with the timeline.
Wait for it…
The Court said a couple of things but, most important, it granted Channel’s request to write a check finding that there was a valid contract and that Boston was capable of performing the contract and that in the end there was no harm to Channel's business resulting from the fraud.
In other news.
Shout out to Tevesol!
Soon to be Amazon for organ shipping.
Slow your roll, Ron Mills… FIRST…
You’ll need a helluva mission.
You gotta build a cutting-edge prototype, then you need some of the world’s smartest docs on your side, the kind that put organs in people,
then get some data,
you’ll need to coordinate these large, third-party, non-profit, organ procurement organizations to support YOU.
You'll probably need to launch it from a large medical center—maybe the biggest one in the world—and you’ll need somebody just crazy and savvy enough to do your regulatory and clinical strategy (blush). You’ll need some nerd glasses…but also to come off super cool…AND have a really killer pitch deck so you can raise a lot of money…
Oh… you did that already?
We love our clients and love you. Tell us what you need or what you want to hear Kevin@ProximaCRO.com
very truly yours,
PS, we’re hiring new positions. Stay tuned to LI and the web. Posting later this week!