01:09:10 Europe / Stockholm

Bifogade filer

Kurs & Likviditet

Kursutveckling och likviditet under dagen för detta pressmeddelande

Beskrivning

LandSverige
ListaSpotlight
SektorHälsovård
IndustriMedicinteknik
BrainCool utvecklar produkter som används inom medicinsk kylning av hjärnan. Teknologin är utvecklad som kylkuddar som appliceras på olika delar av patientens kropp, där systemet kontrollerar kroppstemperaturen. Produkterna används vid behandling av olika allvarliga tillstånd innefattande stroke, hjärtstopp, samt hjärnskakning och migrän. BrainCool grundades 2010 och har sitt huvudkontor i Lund.

Kalender

2022-02-28 Bokslutskommuniké 2021
2021-11-30 Kvartalsrapport 2021-Q3
2021-08-26 Kvartalsrapport 2021-Q2
2021-05-31 Kvartalsrapport 2021-Q1
2021-04-16 Ordinarie utdelning BRAIN 0.00 SEK
2021-04-15 Årsstämma 2021
2021-02-26 Bokslutskommuniké 2020
2020-11-27 Kvartalsrapport 2020-Q3
2020-08-28 Kvartalsrapport 2020-Q2
2020-07-01 Ordinarie utdelning BRAIN 0.00 SEK
2020-06-30 Årsstämma 2020
2020-05-29 Kvartalsrapport 2020-Q1
2020-02-28 Bokslutskommuniké 2019
2019-11-29 Kvartalsrapport 2019-Q3
2019-11-08 Kvartalsrapport 2019-Q3
2019-08-30 Kvartalsrapport 2019-Q2
2019-06-17 Årsstämma 2019
2019-04-08 Ordinarie utdelning BRAIN 0.00 SEK
2019-02-28 Bokslutskommuniké 2018
2018-11-16 Kvartalsrapport 2018-Q3
2018-08-27 Kvartalsrapport 2018-Q2
2018-07-25 Extra Bolagsstämma 2018
2018-05-09 Kvartalsrapport 2018-Q1
2018-04-19 Ordinarie utdelning BRAIN 0.00 SEK
2018-04-18 Årsstämma 2018
2018-02-16 Bokslutskommuniké 2017
2017-11-23 Kvartalsrapport 2017-Q3
2017-08-10 Kvartalsrapport 2017-Q2
2017-06-29 Årsstämma 2017
2017-05-15 Kvartalsrapport 2017-Q1
2017-04-24 Extra Bolagsstämma 2017
2017-04-12 Ordinarie utdelning BRAIN 0.00 SEK
2017-02-14 Bokslutskommuniké 2016
2016-11-10 Kvartalsrapport 2016-Q3
2016-08-25 Kvartalsrapport 2016-Q2
2016-05-10 Kvartalsrapport 2016-Q1
2016-04-14 Årsstämma 2016
2016-03-27 Ordinarie utdelning BRAIN 0.00 SEK
2016-01-28 Bokslutskommuniké 2015
2015-10-22 Kvartalsrapport 2015-Q3
2015-08-26 Kvartalsrapport 2015-Q2
2015-04-28 Kvartalsrapport 2015-Q1
2015-03-27 Ordinarie utdelning BRAIN 0.00 SEK
2015-03-26 Årsstämma 2015
2015-01-27 Bokslutskommuniké 2014
2014-10-20 Kvartalsrapport 2014-Q3
2014-08-19 Kvartalsrapport 2014-Q2
2014-06-26 Ordinarie utdelning BRAIN 0.00 SEK
2014-06-25 Årsstämma 2014
2014-04-14 Extra Bolagsstämma 2014
2021-09-14 22:05:47

Medicare Coverage of Innovative Technology (MCIT) rule is to provide a coverage pathway for medicare beneficiaries to access FDA-cleared or approved breakthrough devices during an initial four-year period after FDA clearance or approval.

Following a previously announced delay in the implementation of the final rule establishing the MCIT pathway, the Centers for Medicare & Medicaid Services (CMS) has now issued a proposal to repeal the final rule prior to implementation on December 15, 2021.

CMS states that it believes there are other ways to achieve the goal of providing innovation and access to important new technologies including future policies and potential rulemaking. CMS is now providing a public comment period of 30 days to allow stakeholders to provide input on the proposed repeal.

Independent of MCIT and the possible outcome, BrainCool has continued the dialogue with Medicare and private healthcare providers of the established clinical evidence for Cooral[® ]System in order to enable a fast access for reimbursement for the product on the US market.

CEO Martin Waleij comments:

"The proposed repeal of the rule is a disappointing setback for the industry and medical device innovation in general.   Given Cooral's clinical evidence and large healthcare costs derived from the unmet medical need of Oral Mucositis, however, we do not believe there will be a material impact on BrainCool's oncology business plan and we are confident of continuing success to secure a comprehensive government and private insurance reimbursement for the Cooral[®] System"

This disclosure contains information that BrainCool is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on  2021-09-14 22:06 CET.