Medical device developer Hancock Jaffe Laboratories yesterday re-set the range on a pending initial public offering, which would fetch roughly $8 million at the midpoint.
Irvine, Calif.-based Hancock Jaffe makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass graft. Last December the company said it planned to float nearly 1.9 million shares at $6 to $8 apiece, for gross proceeds of $11.3 million to $15.0 million, or $13.1 million at the midpoint.
In a new filing yesterday, Hancock Jaffe cut the amount of shares to roughly 1.1 million at the same price range, for gross proceeds of $6.9 million to $9.1 million; each unit would consist of a share of common stock and a warrant for another share, according to the filing. Shares would trade on the NASDAQ exchange under the symbol “HJLI.”
In 2016 Hancock Jaffe dealt its ProCol vascular bioprosthesis to LeMaitre Vascular (NSDQ:LMAT) for $665,000 up front plus a three-year royalty of up to $5 million. The company is developing a bio-prosthetic porcine heart valve for pediatric patients, according to the updated filing.
“Most of the data and studies have been performed to support our submission to the FDA for either a first-in-human study or for an investigational device exemption, or IDE, which we plan to submit in 2019,” the company said.
Hancock Jaffe is also working on the CoreoGraft, bovine-derived CABG designed to eliminate the need for spahenous vein or radial artery harvesting. That product still requires pre-clinical and human studies for FDA approval, the company said in the filing. If those are completed the company said it plans to seek an IDE for a one-year U.S. clinical trial next year.
Finally there’s VenoValve, a porcine valve designed to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis. Made for surgical insertion into the femoral or popliteal vein, VenoValve showed in pre-clinical and in vitro hemodynamic studies that it mimics native valve function.
Those results were submitted to the federal safety watchdog last year as part of a bid for first-in-human study approval, Hancock Jaffe said. The FDA recommended an additional 90-day animal study before first-in-human, the company said.
“We are preparing to commence the additional pre-clinical trial and once completed, we expect to begin first-in-human testing and file our IDE with the FDA in 2019. Once we commence the first-in-human testing, we may seek to obtain reimbursement approval for this product candidate,” Hancock Jaffe said.