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Analyser av Biovica

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Biovica: Continuous high growth from modest absolute levels - Redeye

Biovica records another quarter of modest quarterly IVD test sales growth of 50-55% (compared with the previous quarter), with improving pro...

Redeye • 13 Dec 07:59

Biovica: Significant commercial progress not yet reflected in Q2 sales - Redeye

Biovica records IVD test sales in Q2 of SEK 0.97m , which is 54% above the previous quarter (Q1) and 129% above the earlier quarter (Q4), de...

Redeye • 12 Dec 09:44

Biovica: Signs a US direct client bill contract with one of the largest healthcare providers. - Redeye

The US company is both a health insurance and a health care service provider covering more than 10m lives, and this suggests that this is on...

Redeye • 02 Dec 10:42

Biovica: DiviTum is well placed at the SABCS conference (10-12 December) - Redeye

SABCS (San Antonio Breast Cancer Symposium) is a major annual US cancer conference, and this year, Biovica’s DiviTum test will be featured i...

Redeye • 27 Nov 09:28

Biovica: Secures another Master Service Agreement (MSA) for DiviTum - Redeye

The 15th MSA agreement suggests that Biovica has secured well over 20 MSA-based projects.

Redeye • 17 Sep 13:42

Biovica: High IVD growth - Redeye

Biovica records consecutive quarterly IVD test sales growth of 40-50%, with good prospects ahead.

Redeye • 13 Sep 08:05

Biovica: A considerable boost in the clinical use of DiviTum tests - Redeye

Biovica records IVD test sales in Q1 of SEK 0.62m, which is 50% above the previous quarter (Q4) and 100% above the earlier quarter (Q3), des...

Redeye • 12 Sep 09:38

Biovica: Significant growth at less significant absolut levels - Redeye

Biovica records IVD test sales in Q4, which are higher than Q1-Q3, and research test sales have increased by 300% in 2023/23.

Redeye • 20 Jun 10:50

Biovica: Significant growth at less significant absolut levels - Redeye

Biovica records IVD test sales in Q4, which are higher than Q1-Q3, and research test sales have increased by 300% in 2023/23.

Redeye • 18 Jun 11:03

Biovica: Implements a SEK 30m saving program and an investigation of the US go-to-market strategy - Redeye

Biovica is about to implement an annual SEK 30m cost-saving program.

Redeye • 24 Apr 10:29

Biovica: A positive International Preliminary Report on Patentability (IPRP) - Redeye

Today’s announcement opens the possibility of international patent protection for DiviTum outside the breast cancer space, including the mar...

Redeye • 19 Mar 11:04

Biovica: Commercial progress despite a quarter with modest sales - Redeye

Biovica continues to advance DiviTum among clinical users, but the absolute sales levels are still modest.

Redeye • 18 Mar 07:53

Biovica: Commercial progress despite a quarter with modest sales - Redeye

Biovica’s sales from clinical use of DiviTum tests are up 350% in Q3 compared with the first half, and the Pharma-related sales order book h...

Redeye • 14 Mar 08:57

Biovica: Signs another back-to-back master service agreement for DiviTum TKa testing - Redeye

Biovica, active in blood-based cancer monitoring, has signed a master service agreement, enabling Biovica to provide its TKa testing assay a...

Redeye • 12 Mar 09:26

Biovica: Signs a master agreement for TKa testing with leading pharma company - Redeye

The Master Agreement is distinctly positive and adds to the potential sales contribution, which can be very substantial with an exponential ...

Redeye • 07 Mar 09:52

Biovica: Signs a resourceful Iberian (Spain and Portugal) partner for DiviTum - Redeye

The Palex group of 800 professionals with a long history as a leading provider of advanced solutions for healthcare professionals in hospita...

Redeye • 19 Jan 11:04

Biovica: The rights issue secures SEK 100m before expenses - Redeye

Biovica’s right issue secures SEK 100m, and the number of shares will increase from 45.

Redeye • 15 Dec 2023 14:24

Biovica Update: Approaching increasing recurring revenues - Redeye

The recent Medicare price of USD 322 is the latest progress during a quarter of improved commercial presence including Direct Bill, Hospital...

Redeye • 30 Nov 2023 08:09

Biovica Q2 (August to October): Confirmation about commercial progress - Redeye

The recent CMS Medicare price of USD 322 is the last progress during a quarter of improved presence including Direct Bill, Hospital contract...

Redeye • 28 Nov 2023 09:04

Biovica: The Medicare price is set at USD 322 already from 1 January 2024 - Redeye

The early CMS price decision is good news and the price is in our view within the expected DiviTum price range for the Medicare channel.

Redeye • 21 Nov 2023 11:55

Biovica: Expanding DiviTum’s Nordic market reach - Redeye

Biovica has established a partnership agreement with Axlab (A/S) to commercialize the DiviTum in the Nordics.

Redeye • 13 Nov 2023 12:51

Biovica: A new SEK 120m Rights Issue - Redeye

Biovica commits to a new partly guaranteed (84% covered by commitments, guarantees and undertakings) Right Ussue of units with preferential ...

Redeye • 23 Oct 2023 10:40

Biovica: Signs the third direct bill contract within one month - Redeye

Bivoca has signed a direct bill contract providing access to DiviTum TKa to appropriate patients treated at a leading cancer centre in Flori...

Redeye • 12 Oct 2023 10:30

Biovica: CMS has issued a preliminary Clinical Laboratory Fee Schedule (CLFS) payment decision for DiviTum TKa to pursue the gap-fill process during 2024 - Redeye

The gap-fill process will allow Biovica to secure a Medicare (CMS) code and a preliminary price as of early 2024.

Redeye • 28 Sep 2023 15:00

Biovica: Secures the second larger direct commercial hospital agreement - Redeye

Biovica has signed its second direct commercial client bill agreement with a larger healthcare provider operating 18 hospital laboratories,...

Redeye • 25 Sep 2023 12:47

Biovica: Secures the first larger direct commercial hospital agreement - Redeye

Biovica has signed the first direct commercial client bill agreement with a larger healthcare provider operating more than 30 hospital labor...

Redeye • 19 Sep 2023 11:29

Biovica September Update: Biovica is approaching the first direct contract - Redeye

Biovica has signed three commercial agreements during Q1 but has not yet completed any of the direct contract with hospital chains (or Hospi...

Redeye • 07 Sep 2023 08:09

Biovica Q1 2023/24: Early launch progress - Redeye

Biovica delivers early sales progress with SEK 1.7m in Q1 sales.

Redeye • 06 Sep 2023 08:50

Biovica: Secures a timely PLA code for the US market - Redeye

AMA has approved a specific PLA code for Biovica's DiviTum test that will come into effect by 1st of October later this year.

Redeye • 21 Jul 2023 12:26

Biovica update: US progress - Redeye

Redeye updates our Biovica outlook after reporting the full 2022/23.

Redeye • 26 Jun 2023 07:29

Biovica: Advancing the US launch - Redeye

Q4 highlights that Biovica has secured two contracts with Contigo Health and MedIncrease, access to a respectable proportion of the US priva...

Redeye • 21 Jun 2023 09:19

Biovica: The second US commercial agreement for DiviTum - Redeye

Biovica has signed a provider contract with Contigo Health ConfigureNet provider network.

Redeye • 12 Jun 2023 10:28

Biovica: The first US commercial agreement for DiviTum - Redeye

Biovica has signed a provider contract with MediNcrease Health Plans, a national provider network and provider advocacy firm.

Redeye • 22 May 2023 11:05

Biovica: Outlook for 2023 and 2024 - Redeye

Redeye updated our Biovica outlook after securing access to growth capital and initiating the US and European launch.

Redeye • 12 Apr 2023 09:03

Biovica: The first European commercial partnership - Redeye

Biovica has secured the initial European launch of DiviTum after signing Toro Medical Group as a commercial partnership agreement for the Ne...

Redeye • 29 Mar 2023 10:45

Biovica Q3: US launch progression - Redeye

With the recent CLIA lab certification (the US lab in San Diego), Biovica is moving into the next stage.

Redeye • 16 Mar 2023 10:08

Biovica: The US lab secures the CLIA certification - Redeye

Biovica’s US lab secures a CLIA certification following a successful site visit in January.

Redeye • 08 Feb 2023 12:49

Biovica: Q2 outlook - Redeye

Biovica has secured the SEK 140m new funds in growth capital and the US commercial team is also in place.

Redeye • 15 Dec 2022 11:44

Biovica: Outlook after right issue - Redeye

Biovica has secured a right issue and the next step is the US launch.

Redeye • 09 Dec 2022 10:52

Biovica; Outlook after securing the right issue - Redeye

Biovica has secured a right issue and the next step is the US launch.

Redeye • 09 Dec 2022 10:36

Biovica: Announces a proposed fully guaranteed right issue of SEK 148m (gross) - Redeye

The guaranteed right issue will secure growth capital supporting the US launch and to advance the European commercialisation based on distri...

Redeye • 18 Oct 2022 12:50

Biovica: Aiming for sales start by year-end - ABG

DiviTum could be used to confirm treatment response Path forward toward a sales launch by year-end Q1’22/23 EBIT of SEK -21m, cash positi...

ABG Sundal Collier • 06 Sep 2022 15:02

Biovica Q1 2022/23: FDA Approval - Redeye

Biovica is preparing ahead of the US launch, and the next milestone is to secure a certification for its own lab in San Diego servicing the ...

Redeye • 31 Aug 2022 09:24

Biovica Commercial Update: A US and European launch within 12 months - Redeye

Biovica recently hosted a post-FDA approval commercial update for DiviTum on the 18th of August.

Redeye • 19 Aug 2022 09:02

Biovoca FDA Approval: A late qualifier for a pole position - Redeye

Finally, Biovica has secured US approval (510k) for DiviTum in the core market indication.

Redeye • 01 Aug 2022 07:58

Biovica: Achieves 510(k) clearance for DiviTum - ABG

The long-awaited FDA decision announced on 30 July Management looks to have the test available by year end Opens up USD 200-350m annual ...

ABG Sundal Collier • 01 Aug 2022 07:57

Biovica: Updated timeline for sales start - ABG

FDA decision expected in Q3, potential sales start in Q4 DiviTum shown complimentary to ctDNA Q4’21/22 EBIT of SEK -19m, cash position of SE...

ABG Sundal Collier • 22 Jun 2022 10:38

Biovica Q4 2021/22: The Final Countdown - Redeye

Biovica can point to significant progress lately. The FDA submission was cleared well before schedule, and DiviTum is securing additional sc...

Redeye • 16 Jun 2022 10:27

Biovica and the outlook after the CMD: A road map to the US market

Biovica’s CLIA certified San Diego lab, together with the summer of 2022 FDA 510 (k) approval is the backbone of Biovica’s strategy to reach...

Redeye • 19 May 2022 11:25

Biovica: Takeaways from Capital Markets Day - ABG

Demand generation important for CLIA lab strategy Multiple angles to market the product US launch will follow after 510(k) decision Upda...

ABG Sundal Collier • 18 May 2022 15:11

Biovica FDA Submission: Goal in Sight - Redeye

Biovica has now submitted the updated FDA application.

Redeye • 29 Apr 2022 10:17

Biovica Q4: The FDA process is live and Biovica prepares for the launch with expanding clinical support - Redeye

The essential Q3 (November-January) feedback is that the FDA process progresses without significant internal or external disruptions.

Redeye • 15 Mar 2022 09:43

Biovica: Fundamental support and an administrative delay - Redeye

When Biovica announced that the FDA was not yet ready to accept Biovica’s updated application, this triggered a severe negative overreaction...

Redeye • 15 Sep 2021 11:29

Biovica: The submission of the updated application will be slightly delayed - Redeye

Biovica's next step before the FDA decision is to formally submit the updated application after addressing all FDA's questions from earlier ...

Redeye • 14 Sep 2021 07:49

Biovica: Closing in on the finish line - ABG

510(k) clearance feedback could be one month away Appointment of President of the Americas Q1’21/22 EBIT of SEK -12.

ABG/Introduce • 06 Sep 2021 07:37

Biovica: FDA approval in sight - Redeye

Redeye's Q1 conclusion is that the US DiviTum approval is on track and that a decision is likely in September alternatively after addressing...

Redeye • 31 Aug 2021 12:39

Biovica: A partly understandable overreaction earlier today - Redeye

The local and regional peer company, Arocell, withdrew the FDA application and may reapply a De Novo submission in due course.

Redeye • 11 Aug 2021 15:39