Press Releases


FDA informs that the review of AroCells 510(k)submission will resume at the latest April 15th 2021

AroCell announced today that the US Food and Drug Administration (FDA) has informed that they will resume the review of AroCells 510(k) submission no later than April 15th 2021.

The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has been actively engaged in responding to the current pandemic caused by a novel coronavirus (SARS-CoV-2) and the associated disease it causes (COVID-19). Due to the on-going national emergency and the large number Emergency Use Authorization (EUA) requests, FDA have received for in vitro diagnostics (IVDs), staff and managers have been reallocated to complete the review of these requests. This has caused a delay in handling of other 510(k) submissions. The review of AroCell´s 510(k) submission will be resumed no later than April 15th 2021.
 

AroCell AB (publ) Interim Report January 1st to December 31st, 2020

A word from the CEO
”2020 was a groundbreaking and eventful year for AroCell with high activity in many areas. Since Michael Brobjer took over as CEO in 2018, the management's goal has been to transform the company from a research-oriented company to a commercially driven company. In 2020, we have come a long way in reaching the goal and have strengthened the organization with additional expertise, and implemented our regulatory plan.

During the year, the company submitted a 510(k) application to the FDA where the goal is to obtain clearance to be able to sell AroCell TK 210 ELISA for clinical use in the US. We consider the approval in the US as a very important strategic step in spreading knowledge about the benefits of measuring TK1 and thus in the long run get the product to be used and generate revenue.”

Anders Hultman, CEO

Reporting period October 1st - December 31st

  • Net sales were 20 (120) KSEK
  • Loss before financial items was -6 012 (-6 034) KSEK
  • Cash flow from operating activities was -3 834 (-3 787) KSEK
  • Earnings per share before and after dilution were -0.08 (-0.15) SEK
  • Cash and cash equivalents were at the end of the period 42 014 (13 631) KSEK

Reporting period January 1st - December 31st

  • Net sales were 84 (443) KSEK
  • Loss before financial items was -24 052 (-20 736) KSEK
  • Cash flow from operating activities was -18 902 (-15 055) KSEK
  • Earnings per share before and after dilution were -0.33 (-0.53) SEK
  • Cash and cash equivalents were at the end of the period 42 014 (13 631) KSEK

Events during the reporting period October 1st - December 31st

  • The FDA reports delays in the timeline for reviewing 510(k) applications, due to a large number of Emergency Use Authorization (EUA) requests they have received in in-vitro diagnostics (IVDs) due to COVID 19. Redistributions of staff and resources are expected to affect the timeline for reviewing applications. The FDA estimates the delay at about 90 days, which will delay the review of AroCell's 510(k) application.
  • AroCell announced that a new article has been published in the Journal of Immunological Methods. The article indicates that it is possible to design diagnostic algorithms for biomarkers that can help distinguish Mycoplasma pneumonia from other respiratory infections caused by bacteria or viruses.
  • AroCell informed about the composition of the Nomination Committee before the 2021 Annual General Meeting.

Events after the reporting period

  • Anders Hultman, the company's CFO, was appointed new CEO of AroCell. Former CEO Michael Brobjer has resigned at his request but will remain in the company until April 30 as CCO.
  • AroCell announced that Jonas Söderholm has been recruited to the management team as Global Medical Lead. Jonas will lead and develop AroCell's clinical program with a focus on obtaining more clinical evidence for the use of TK1 as a biomarker in cancer treatment.
  • FDA informs about further delays. The COVID-19 pandemic has led to the redeployment of FDA personnel, leading to further delays in reviewing FDA applications. The delay is extended by another 90 days.
  • Gunnar Steineck was appointed as Chief Medical Officer at AroCell. Gunnar has until now been interim CMO but now has the role permanently. Gunnar has extensive experience as both an oncologist and clinical researcher.

Interim report January 1st - December 31st, 2020 (available in Swedish only) (Link)

AroCell appoints Gunnar Steineck as CMO

AroCell announces today that Professor Gunnar Steineck has been appointed Chief Medical Officer at AroCell. Gunnar has been a temporary CMO for five months and now takes the role permanently. Gunnar has extensive experience as an oncologist and clinical researcher.

Gunnar Steineck has more than 35 years of experience in research in the medical field. After studying mathematics, statistics, and medicine at Uppsala University, he was trained as a specialist in oncology and radiation therapy at Karolinska University Hospital. After a Ph.D. (1990), Gunnar became an associate professor (1992). This was followed by post-doctoral studies at the Memorial Sloan-Kettering Cancer Center in New York. In 2002 he was appointed professor at Karolinska Institutet and in 2004 professor of clinical cancer epidemiology at the University of Gothenburg. The focus of his research since the 1990s has been to retrieve knowledge that can be used to cure cancer with restored health in the cancer survivor. Gunnar has more than 350 articles published in peer-reviewed journals. They include studies of markers, surgery, radiation therapy, and cytotoxic drugs.

“I have known Bernhard Tribukait since the 1980s, one of the two researchers behind AroCell's products”, says Gunnar Steineck. “Being able to help so that his important research regarding thymidine kinase benefits patients is a great joy”.

“I am very pleased that Gunnar is taking on this position permanently. His experience and knowledge in oncology, not least uro-oncology, are very valuable to AroCell. Gunnar has previously made significant contributions in his role as interim CMO and a board member as well as in specific consulting assignments ", says Anders Hultman, CEO of AroCell.

FDA informs about another delay due to Covid-19

AroCell announced today that the US Food and Drug Administration (FDA) has informed once again that the impact of the COVID-19 pandemic and the reallocations of staff is leading to an even greater prolonged timeline for reviews of submissions. FDA informed that the delay is prolonged with another 90 days and will prolong all submission review.

FDA’s Center for Devices and Radiological Health (CDRH) has been actively engaged in responding to the current pandemic caused by a novel coronavirus (SARS-CoV-2). They state that due to the sustained volume of EUA (Emergency Use Authorization) requests and continued importance of testing in the response to the pandemic, they are not yet able to resume the review of submissions.

AroCell will receive updates regarding the anticipated timeline for the resources on the non-COVID related activities.

AroCell strengthens the team – recruits a Global Medical Lead

AroCell AB (publ.) announces today that Jonas Söderholm joins the management team as Global Medical Lead. Jonas will lead and develop AroCell’s clinical program with a focus on getting more clinical evidence for the use of TK1 as a biomarker in cancer treatment.

Jonas has a Ph.D. in Biomedical Laboratory Science at Karolinska Institutet, supervised by Professor Matti Sällberg, and a Bachelor of Business Administration from the School of Business, Economics, and Law at the University of Gothenburg. He is most recently coming from AbbVie Scandinavia, where he has been working since 2013 on several different positions including Medical Lead, Medical Advisor, and Research Lead in areas such as Gastroenterology, Rheumatology, and Virology. At AbbVie, he has been part of several successful launches of new products. Jonas will report to the CEO and work closely with the rest of the management team to coordinate AroCell’s clinical program as well as to spread awareness around the benefit of measuring TK1 with AroCell TK 210 ELISA.

Jonas has deep knowledge within the medical areas as well as in business development. He has extensive experience working closely with “Key Opinion Leaders” (KOLs), conducting clinical studies and generating publications.

“We are very happy to welcome Jonas to the AroCell team. Jonas possesses valuable expertise and experience which are well suited for us. He will unquestionably strengthen our company even further and help us in our efforts to make AroCell TK 210 ELISA available to patients with cancer", says Anders Hultman, CEO of AroCell.

“I'm looking forward to start working at AroCell. It will be exciting to contribute with my experience and to improve the patient care in several types of cancer “, says Jonas Söderholm.

Jonas will start his new position on April 12, 2021.

AroCell appoints new CEO

AroCell AB today announces a safe and smooth transition to a new CEO of the company.

Former CFO Anders Hultman has been appointed new CEO. During the more than two years he has been at AroCell, Anders has done an exceptional job together with the former CEO Michael Brobjer, which enables a simple and smooth transition to the new role. Anders is very well acquainted with the company's strategies and plans to take the AroCell TK 210 ELISA to the next level. In addition to a solid experience as CFO, Anders has the business acumen needed for a demanding CEO assignment. He has previous experience of successfully running both listed and unlisted companies in various industries.

"I am honored to take over as CEO after Michael Brobjer. AroCell has a fantastic product and is in an important and interesting phase where full focus is on the strengthened commercialization of AroCell TK 210 ELISA. I look forward to leading AroCell to the next phase together with our professional team ", says CEO Anders Hultman.

Former CEO Michael Brobjer has resigned at his request. He and his family are going on a longer sailing voyage. Michael resigns today as CEO and thus enables a smooth transition for the new CEO Anders Hultman. During the remaining time at the company, Michael will focus on the launch of AroCell TK 210 ELISA in the US prior to the FDA approval of AroCell's 510(k) submission. Michael will work his last day at AroCell on April 30th  but will continue as a consultant for AroCell.

"I look forward with great excitement to AroCell's continued journey and am convinced of its success. At the same time, I am on my way to the adventure of my life, something that we in the family promised each other many years ago. It will be very exciting to follow AroCell's continued development from the oceans ", says former CEO Michael Brobjer.

“Michael Brobjer has made a great contribution to AroCell and through his leadership taken the company to a new level. I am pleased that through the appointment of Anders Hultman, we can confidently ensure that AroCell continues to pursue its successful work to offer a better tool to support oncologists in the treatment of cancer while placing further focus on our US launch," said Claes Post, Chairman of the Board at AroCell.