• 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 » Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell

Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell

March 4, 2019 By Fink Densford

Avita Medical

Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal.

The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to administrative and procedural non-conformities,” but said that the action has no impact outside the EU and that issues are not related to product quality, safety or performance.

Avita said that it does not actively promote the product in the region and that activity there is limited to filling purchase requests as they are received, with an average of $40,000 in sales per month.

“It is important to note that this interruption is unrelated to the performance and safety of our products and does not impact the U.S. market. We will work closely with the authorities to close this administrative request as soon as possible, and no later than the 3rd quarter of calendar 2019. We do not actively promote in the EU at this time but do want to ensure that our products are available as soon as possible to those institutions who request it and to patients who can benefit from their use,” Avita CEO Dr. Mike Perry said in a press release.

In a separate release, Avita said that it inked a Japanese marketing and distribution deal with Cosmotec, who recently filed with the country’s Pharmaceuticals and Medical Devices Act, or JPMDA, for approval of Avita’s Recell system.

Avita said that the JPMDA has accepted the application for review and that the review is expected to take nine months to one year. Financial terms of the deal with Cosmotec were not released.

“The number of patients suffering from chronic wounds and decubitus ulcers is increasing in Japan due to aging. Japan is also planning for the Tokyo Olympic Games in 2020 and must be prepared for major disasters such as a large earthquake. We are very proud to add the Recell System to our product lineup. With over 30 years since our foundation, Cosmotec has been doing business in 90-100% of high acute care hospitals in Japan in the fields of cardiac surgery, vascular surgery, and wound care. As a member of the M3 Group, we can deliver the Recell System’s benefits to at least 90% of Japanese plastic surgeons and dermatologists through the portal site ‘m3.com.’ With this opportunity, we would like to contribute to the advancement of burn injury and wound care in Japan,” Cosmotec prez Kiyoshi Takei said in a prepared statement.

“We are very excited to partner with Cosmotec on the commercialization of the Recell System in Japan, a key global market. Cosmotec’s experience marketing medical devices and other products into hospitals and surgical suites throughout Japan, including specialties requiring a high level of training such as cardiovascular treatment, make them an ideal partner for us. We are also pleased that they are backed by the M3 Group, a major healthcare company with great physician access in Japan and other markets. The filing of the JPMDA application is a major milestone, and we look forward to making the Recell System available to patients in Japan,” Perry said in a press release.

Last month, Avita Medical reported raising approximately $14.4 million in a new round of equity financing, according to an SEC filing.

Filed Under: Business/Financial News, Distribution, Featured, Regulatory/Compliance, Wound Care Tagged With: avitamedical

In case you missed it

  • House committee investigates $70M federal contract for AutoMedx ventilators
  • Edwards Lifesciences misses on earnings in Q4
  • COVID-19 assays sales power Hologic to Street-beating Q1
  • Stryker beats the Street on earnings but misses on revenue in Q4
  • How CGMs can inspire lifestyle changes
  • Johnson & Johnson gearing up for COVID-19 vaccine data announcement
  • Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer
  • Adapting to Pharma’s Next Normal – 2021 Pharmaceutical Trends
  • COVID-19 test sales boost Abbott in Street-beating Q4
  • Varian posts mixed bag Q1 results, expects Siemens Healthineers takeover to complete in early 2021
  • BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
  • Titan Medical closes on $11.5M offering
  • GE ticks up on mixed-bag Q4
  • BD CEO Polen to also serve as board chair
  • Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants  
  • Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
  • Longeviti Neuro Solutions ClearFit implant wins FDA clearance for use in ultrasound

RSS From Medical Design & Outsourcing

  • House committee investigates $70M federal contract for AutoMedx ventilators
    A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19. The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to… […]
  • How CGMs can inspire lifestyle changes
    As an early adopter of fitness trackers such as the Fitbit, I’ve long appreciated the power of health data. But my recent experience with a continuous glucose monitor (CGM) has done far more to inspire me to look after my health — even as a nondiabetic. I had heard about the potential of such technology… […]
  • COVID-19 mask factory opens in N.J.
    Hudson Holdings Group today announced it has opened a factory to make up to tens of millions of protective masks a month. The Piscataway, N.J., site will produce more than 200 jobs, according to the company, which is in partnership on the project with the State of New Jersey. “Our ultimate goal is to help,”… […]
  • TE Connectivity posts Street-beating Q1 results, medical sales dip 12%
    TE Connectivity (NYSE:TEL) posted first-quarter results today that beat the consensus on Wall Street. The Schaffhausen, Switzerland-based company reported profits of $381 million, or $1.13 per share, on sales of $3.5 billion for the three months ended Dec. 31, 2020, for a bottom-line gain of 1365.4% sales growth of 11.2% compared with Q1 2020. Adjusted to… […]
  • Could this 3-D printed ‘biomesh’ minimize hernia repair complications?
    Some hernia mesh implants have been associated with adverse post-surgical complications. So researchers at Baylor College of Medicine have developed a 3D-printed biomesh to support and reinforce the damaged abdominal wall and facilitate the healing process. Mesh implants may fail because they promote the adhesion of the intestine, liver or other visceral organs to the… […]
  • Superior Sensor Technology launches versatile differential pressure sensors
    Superior Sensor Technology (Santa Clara, Calif.) today announced the launch of differential pressure sensors for industrial applications that support up to seven selectable pressure ranges in one device. Designed for a wide range of applications, the new ND Series sensors support pressure ranges as low as 62.5 Pa/0.25” H2O to as high as 345 mBar/5… […]
  • BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
    Becton Dickinson (BD) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2. The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth… […]
  • TDK adds pressure sensors for ventilators
    TDK Corporation announced the launch of a new range of differential pressure sensors designed as printed circuit boards for use in medical devices. The sensors are designed for measurement ranges of 16 mbar full-scale (FS), 100 mbar FS and 7 bar FS, with accuracy of up to ±1% FS at temperatures from -20 °C to… […]
  • Pediatric device workshop scheduled for February
    A virtual public meeting on pediatric medical device development is scheduled for Feb. 9-11, 2021. Sponsors include the FDA, AdvaMed, the American Academy of Pediatrics and the Critical Path Institute, a public-private partnership that receives FDA funding. The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop will focus on the… […]
  • Pedra wins breakthrough nod for perfusion system
    Singapore-based Pedra Technology announced today that the FDA has granted the company breakthrough device designation for the periprocedural use of its Xauron perfusion system in the treatment of critical limb-threatening ischemia (CLTI). CLTI is a severe form of peripheral artery disease (PAD) that is defined as ischemic rest pain, tissue loss or gangrene (tissue death) that… […]
  • Freudenberg Medical expands U.S. molding operations
    Freudenberg Medical announced that it has expanded injection molding operations at its Baldwin Park, Calif., operation, which is focused on thermoplastics. Freudenberg Medical Baldwin Park has added six injection molding machines including three new Arburg molding machines, a work cell for two-shot molding and a Wittmann Battenfeld micro-molding machine with in-process visual inspection capability. The… […]

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