• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » ReGen Biologics: We’re too broke to file our annual report

ReGen Biologics: We’re too broke to file our annual report

March 31, 2011 By MassDevice staff

FDA, ReGen Biologics

ReGen Biologics Inc. (PINK:RGBO) doesn’t have enough money to pay for its annual earnings filing with the Securities & Exchange Commission.

The embattled maker of the Menaflex knee implant, which has been in a protracted and public battle with the FDA for nearly two years, said in a regulatory filing that, “due to an inability to obtain adequate external financing the registrant has not been able to complete the necessary accounting and internal control procedures required for preparing the Form 10-K and management could not complete Management’s Discussion and Analysis of the financial and other information required to be included in the Form 10-K.”

Regen officials said they do not expect to file the form until after the company has secured additional outside funding.

The news adds yet another layer to ReGen story, which captured the attention of the medical device industry as the Menaflex saga with the Food & Drug Administration unspooled. Last October, the FDA said it will rescind the 510(k) clearance it granted the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage, in late 2008.

The rescission means Hackensack, N.J.-based ReGen has to keep the device off the U.S. market until it can prove its safety and effectiveness to the FDA’s satisfaction.

ReGen wasn’t shy about voicing its displeasure over the rescission, with CEO Gerald Bisbee calling it “totally unbelievable.”

The FDA said it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness," five years after the company began the 510(k) application process.

ReGen has sunk $30 million into meeting requirements set by the FDA’s Center for Devices & Radiological Health, according to Bisbee, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true.”

The Menaflex 510(k) clearance in December 2008 came over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.

In March, the agency’s Orthopedic & Rehabilitation Devices Panel decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.

“It’s unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong,” Bisbee said in prepared remarks on March 22. “This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval.”

That wasn’t the only shot Bisbee fired across the FDA’s bow.

“We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage,” he said. “After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients.”

Filed Under: Food & Drug Administration (FDA), MassDevice Earnings Roundup, News Well, Wall Street Beat Tagged With: Q4, ReGen Biologics Inc.

In case you missed it

  • These medtech stocks performed the best in 2020
  • Medtronic launches deep brain stim trial for Parkinson’s disease
  • Former FDA commissioner Kessler to help lead Biden’s COVID-19 response
  • Facial swelling and COVID-19 vaccines: 4 facts
  • Here’s what molecular shape can tell you about pharma innovation
  • Norway investigating deaths of 23 individuals who received COVID-19 vaccine
  • 3M, Honeywell gain antitrust protection to boost N95 mask supply
  • Leading Medical UX Trends
  • Ex-Acclarent execs fined $1.5M in off-label marketing case
  • Former CDER head Woodcock to lead FDA for now
  • Prosecutors want to present evidence of Elizabeth Holmes’ quest for wealth and fame
  • TransEnterix raises more than $31M in stock offering
  • Boston Scientific launches WaveWriter Alpha spinal cord stim
  • What’s next for the FDA and for Stephen Hahn?
  • Apple magnetic charger, smartwatch may deactivate Medtronic ICD
  • Medicare to cover breakthrough devices
  • FDA debuts plan for AI-based Software as a Medical Device

RSS From Medical Design & Outsourcing

  • These medtech stocks performed the best in 2020
    While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while… […]
  • Covestro tests plastics against high-strength hospital disinfectants
    Covestro announced that it recently teamed with disinfectant manufacturer Metrex to test six different Covestro polycarbonate materials against three of Metrex’s products, which are widely used throughout the healthcare industry. As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were pre-strained and underwent several wipe-and-dry cycles with Metrex disinfectants to… […]
  • Integer expands N.Y. battery plant
    Integer announced today that it recently broke ground on an expansion of its Alden, N.Y., facility to accommodate new equipment that will substantially increase the plant’s production capacity for rechargeable Xcellion lithium-ion batteries. The project kicked off in mid-December 2020 and will add both production equipment and a build-out of Integer’s existing facility. The company… […]
  • Diversified Plastics adds high-efficiency vertical presses
    Diversified Plastics (DPI) announced that it recently installed six all-electric vertical injection molding presses. These presses will join DPI’s existing assemblage of vertical presses and provide increased production capacity to meet growing demand from medical device and other original equipment manufacturers (OEMs). DPI uses vertical presses for over-molding and insert-molding, capabilities often required for medical… […]
  • Traco Power expands power supply line for portable medical equipment
    Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. Key approvals on the original series remain on the expanded… […]
  • Reflow Medical launches low-profile reinforced support catheters
    Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with… […]
  • Former CDER head Woodcock to lead FDA for now
    FDA veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports. An article by BioCentury also said that former FDA commissioner David Kessler, who had been mentioned as a possible replacement for current commissioner Stephen Hahn, will be a consultant to the agency but will not… […]
  • What’s next for the FDA and for Stephen Hahn?
    Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year. It’s hard to blame him. Hahn’s brief tenure at FDA has been rocky, to say the least. (News of his temporary replacement broke on Thursday, when the incoming Biden administration… […]
  • Medicare to cover breakthrough devices
    FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices… […]
  • FDA debuts plan for AI-based Software as a Medical Device
    The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD). The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” It outlines five actions that the FDA… […]
  • EU allows remote audits for medical devices during pandemic
    The European Union has announced that it will temporarily allow remote audits of medical devices and in vitro diagnostics under the new regulations (MDR IVDR), set to go into effect on May 2021 and 2022 respectively. In a document published Monday, the European Commission agreed with industry and notified bodies that the ongoing COVID-19 pandemic… […]

Leave a Reply Cancel reply

You must be logged in to post a comment.

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS