San Antonio — Effectively pulling off a change in management is no small feat. For Invictus Medical, it may be even more difficult because the departure of its long-time CEO, Tom Roberts, occurred at the same time the company is working to introduce a couple new products and clinch the first sales of its lead product.
Acting CEO Dennis Kane says the San Antonio medical device maker has developed a new activity sensor that it plans to incorporate into its lead device, the GelShield. That product is a headband that is placed around a newborn baby’s head—particularly those born prematurely—and is intended to prevent pressure from building on the skull. The new sensor, which will be part of the GelShield, will be able to monitor the infant in a hospital’s neonatal intensive care unit, from the baby’s sleep to any movement, Kane says.
The company plans to seek regulatory approval for the product in the next year. Invictus received FDA clearance to market its GelShield device, which aims to prevent “flat spots” that sometimes appear on newborns, in May 2015.
Invictus is still seeking its first orders of GelShield, Kane says. The company spent the first six months after approval working with potential sales partners on the product and making slight tweaks to its design. The company removed an edge that was causing redness on the newborns’ foreheads and added silicone to make sure the device holds to the head, Kane says.
He says the company has a few potential hospital clients.
“Procurement for new tech in hospitals is not fast,” Kane says.
Meanwhile, the company is in the process of licensing a technology from an unnamed university that is meant to reduce noise in neonatal ICUs, Kane says.
It makes the space inside the baby’s incubator “more like the womb from which they came,” Kane says in a telephone interview.
Xconomy reported at the start of July that Roberts, who joined Invictus in 2012, was leaving the company. Kane says that Roberts, after spending four years building the company to the point of achieving FDA clearance to sell its first medical device, wanted to spend time with his family.
“He was tired—four years at a startup is a lot,” Kane says.
Kane, an Invictus board member who has experience in the pharmaceutical industry, decided to step into the top executive role temporarily, he says. The company wanted to build a stable sales foundation before hiring a new permanent CEO, rather than spend time and capital on a long hiring process, Kane says.
Kane is a former executive at Phadia AB, a Swedish company that sold allergy and autoimmune disease diagnostic products. Phadia was acquired by Thermo Fisher Scientific for $3.5 billion in 2011 and was renamed ImmunoDiagnostics. Phadia was originally created as Pharmacia Diagnostics, an independent company established after Pfizer acquired Pharmacia (and Kalamazoo, MI-based Upjohn Company) in 2003.
The GelShield product is working well, Kane says, adding that he knows from experience. His three-month-old grandson used one after being born premature.
