MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Kips Bay Medical shares reach new low on FDA setback for surgical mesh

Kips Bay Medical shares reach new low on FDA setback for surgical mesh

By

Kips Bay

Kips Bay Medical Inc. (NSDQ:KIPS) shares sank hard and fast on news that the FDA asked for additional information before allowing its eSVS surgical mesh to undergo clinical testing.

The Minneapolis-based company lost 34 percent yesterday, closing at $1.87 (compared to a close of $2.85 on Sept. 20). Along the way, shares hit an all-time low of $1.79.

Kips’ eSVS surgical mesh, a flexible device used to strengthen vein grafts during coronary artery bypass procedures, is under consideration for an investigational device exemption to begin conducting clinical trials toward U.S. marketing clearance. The FDA told the company that it needs to provide more data to support its application, according to a press release.

"While we are disappointed with the news from the FDA, we remain confident that our European studies will demonstrate the improved patency of grafts treated with the eSVS Mesh as compared to untreated grafts," chairman and CEO Manny Villafana said in prepared remarks. "We will then present this data to the FDA as further evidence supporting our request for an IDE."

The company is pursuing clinical studies in Europe and the United Arab Emirates in hopes of obtaining the necessary data to satisfy IDE status for the FDA.

Kips Bay stock has plummeted 78 percent since February, when it hit a high-water mark of $8.37 shortly after launching an initial public offering, which opened at $8.00 and raised $17 million on a hoped-for $21.2 million offering.

Shares have dropped pretty steadily since then, hitting the halfway mark of $4.00 by mid-May as sales of the company’s flagship mesh device have lagged.

The eSVS device won CE Mark in the European Union in May 2010, but sales have lagged.

"[W]e have not generated significant revenue from the sale of products to date," the company wrote in the Jan. 18, 2011, filing.

Kips managed to narrow losses heavily in the three months ended July 2, 2011, reporting $1.04 million lost, 82 percent less than the $5.9 million lost during the same period in 2010. Sales remained steady at $48,000 compared to last year.

In case you missed it

RSS From Medical Design & Outsourcing

  • EPA delayed notifying residents of ethylene oxide emissions
    The EPA delayed notifying neighbors of an Illinois medical device sterilization plant of ethylene oxide (EtO) emissions the agency measured in 2018, according to an inspector general’s report released yesterday. The report also says that “leadership” in the agency’s Office of Air and Radiation also failed to conduct public meetings with residents either near the… […]
  • 9 medical devices you should keep an eye out for in 2021
    The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021. Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek… […]
  • Greenlight Guru to provide QMS to NIH diagnostics program
    NIH has chosen Greenlight Guru to provide quality management software for its COVID-19 rapid diagnostics program. The agency launched the Rapid Acceleration of Diagnostics (RADx) program in March 2020 to speed the development, commercialization and implementation COVID-19 testing technologies. As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru… […]
  • MicroCare names CFO
    MicroCare (New Britain, Conn.) has announced the appointment of John Stardellis as the company’s new chief financial officer (CFO). Stardellis joins MicroCare with more than 20 years’ experience in a variety of finance, policy and operational leadership roles. Most recently, he served as CFO at i-Health, a division of DSM Nutritional Products. “John’s track record with… […]
  • Mayo Clinic helps launch two new companies for improved diagnostics
    Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release. Get the full story… […]
  • Intertek gains FDA nod for premarket device testing
    Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week. The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market. The Accreditation Scheme for Conformity Assessment pilot program is a voluntary program developed to provide increased confidence in testing… […]
  • HHS shoots down ‘flawed’ plan to let some devices skip review
    The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review. HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with… […]
  • More than 50 medtech testing sites win FDA pilot accreditation
    The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews. In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market… […]
  • Medline Industries up for sale?
    Medline Industries is looking for a buyer in a deal that could be worth $30 billion, according to a report in the Wall Street Journal. The Journal cites “people familiar with the matter” saying that Northfield, Ill.-based Medline has hired Goldman Sachs to manage the process. The people added that the company might alternatively seek… […]
  • Micro to add plant in Costa Rica
    Contract manufacturer Micro today announced plans to open a new plant in Costa Rica. The 32,000 ft² facility will significantly increase Micro’s cleanroom assembly capacity, according to the Somerset, N.J.-based company. It will be located in the Zona Franca Metro business park and is expected to open in late 2021 with operations beginning in 2022.… […]
  • Survey shows solid medical device industry performance despite pandemic
    By Stewart Eisenhart, Emergo Group Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not… […]

Leave a Reply