Non-opiate Painkilling Gel Maker InSitu Biologics Looking to Raise $1M
Veteran Twin Cities inventor and medtech entrepreneur Jim Segermark of InSitu Biologics is out raising $1 million after getting encouraging results from pre-clinical tests of a novel non-opiate painkilling gel, according to a recent filing.
The Regulation D filing with the U.S. Securities Exchange Commission, made on Nov. 22, indicates St. Paul-based InSitu and CEO Segermark are seeking up to $1 million in equity from accredited investors as they look to enter what they call “a $31 billion annual market for peri-operative pain management.”
The fundraising is coming less than a year after the company reported positive results from pre-clinical studies at the University of Minnesota for InSitu’s lead product, AnestaGel, described as a long-lasting, non-opiate local painkiller for use in peri-operative regional pain management originally developed by scientists at the Cleveland Clinic in conjunction with Chaska-based LifeCore BioMedical.
The study results, released in January 2017, claimed that AnestaGel proved to be longer-lasting and provided more analgesic effect than Exparel from Pacira Inc., currently the industry standard in sustained-delivery post-operative pain relief.
InSitu’s product is based around the use of its proprietary Matrix BioHydrogel as a platform for drug delivery. The company claims the gel provides a “tunable, biocompatible and pH neutral platform” to deliver the analgesic in a timed-release manner when injected near surgical incisions. This process is “site-specific, non-migratory and flexible,” and features a “high dose drug-load reservoir capacity.”
The key to Matrix BioHydrogel technology, according to a 2016 white paper, is its three-dimensional amino acid crosslinking, which produces a viscosity tailored to a consistency approaching peanut butter. Matrix BioHydrogel-based AnestaGel boasts “contiguous three-dimensional molecular uniformity in a three-dimension lattice,” while the Exparel platform, in contrast, is “amorphous,” affecting “degradation, elution and migration.”
This, the paper contends, raises concerns for toxicity through unintentional analgesic release and migration away from the surgical site.
After announcing the pre-clinical results in January, Segermark said in an issued statement, “We look forward to the next steps that will bring this predictable, very long-acting, non-opiate product to patients that face the prospect of post-surgical pain.”
InSitu is initially pursuing applications for soft and bone tissues.
According to his biography, Segermark has acted as founder, inventor, investor and owner-operator of numerous medical device ventures, including Eight Medical Corp., a hyperthermic lavage system which was cleared by the U.S. Food and Drug Administration and eventually sold in 2012.
Segermark is probably best known as the founder, chairman and “first patient” of VMBC LLC, maker of the Vasclip vasectomy device, from 2001 to 2007, and ViaMedics LLC, a designer and manufacturer of proprietary medical devices. He also served in senior management positions at Microvena Corp. of White Bear Lake throughout most of the 1990s.
InSitu is based in offices at the renovated former Hamm’s Brewery site on St. Paul’s East Side.