Bio-Plexus
This article was originally published in The Gray Sheet
Executive Summary
Plans to go public via offering of 1,333,000 shares of common stock priced between $11 and $13, according to a prospectus filed with the Securities and Exchange Commission. The Tolland, Connecticut firm's first product, the Punctur-Guard safety needle for blood collection, was cleared by FDA in 1990 and launched in June 1993. The device "is the only safety needle on the market rendered safe prior to its removal from the patient," the firm claims. Bio-Plexus is working on two other Punctur-Guard devices including an IV catheter and "winged needle" IV set. The IV catheter is expected to enter clinicals in 1995; clinicals for the IV set will not begin until "after the development of the IV catheter is substantially complete," the company says.
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.