DSR

EQS-News: Photon Energy Group Secures Polish Capacity Market Contracts for 316 MW, Locking in Revenues of EUR 13 Million for 2025

Retrieved on: 
Wednesday, April 10, 2024
Photon, EUR, DSR, Photon energy, FSX, Growth, Q1, Electricity, Acquisition, Q4, PLN, HVAC, Q3, Costochondritis, Demand-side, Renewable energy

Photon Energy Group Secures Polish Capacity Market Contracts for 316 MW, Locking in Revenues of EUR 13 Million for 2025

Key Points: 
  • Photon Energy Group Secures Polish Capacity Market Contracts for 316 MW, Locking in Revenues of EUR 13 Million for 2025
    The issuer is solely responsible for the content of this announcement.
  • Photon Energy Group Secures Polish Capacity Market Contracts for 316 MW, Locking in Revenues of EUR 13 Million for 2025
    As a result of additional auctions for 2025, the Company concluded contracts for 316 MW (out of which 315 MW is DSR capacity) in addition to the previously contracted 10 MW for the same year, ensuring PLN 56.1 million (EUR 13 million) in revenues for 2025.
  • With the previously contracted capacity of 10 MW for 2025, the Company’s total capacity obligation of 316.088 MW will ensure PLN 56.1 million (EUR 13 million) in Capacity Market revenues for 2025.
  • Photon Energy participated and secured 316 MW in capacity, with 315 MW designated for DSR (Demand Side Response) units.

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
Wednesday, April 3, 2024
Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

Sequana Medical announces three month follow-up data from MOJAVE non-randomized cohort confirming dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR® therapy

Retrieved on: 
Monday, March 25, 2024
Cardiorenal syndrome, Congestion, Myocardial infarction, DSR, Brussels Stock Exchange, Liver disease, Partnership, RED, Patient, 2.0, Blood urea nitrogen, Cancer, Fluid, Heart, Heart failure, Furosemide, EGFR, Safety, DSMB, Overload, Hyponatremia, Hypertension, Pharmaceutical industry

These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.

Key Points: 
  • These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.
  • Unlike loop diuretics which, on average, have a negative impact on renal function and diuretic response, DSR has again demonstrated its potential to restore renal health and control of volume status.
  • Dramatic improvement in diuretic response and stable kidney function: During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics.
  • In January 2024, the independent DSMB approved the start of the randomized MOJAVE cohort following review of the safety data reported from the non-randomized cohort.

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.

SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT AND PROVIDES TRADING UPDATE

Retrieved on: 
Wednesday, March 20, 2024
EUR, Partner, Tax, DSR, Offering, Liver disease, FY, Ketel One, KBC, International, Committee, Financial services, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, FSMA, Person, European, EQT, LSP, PMA, US FDA, Overload, Stock, Marketing, Transaction, Security (finance)

(ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.

Key Points: 
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • The Offering shall be structured as a private placement of new shares via an accelerated bookbuilding, which will commence immediately.
  • Trading in Sequana Medical shares on the regulated market of Euronext Brussels will be suspended during the bookbuilding period.
  • Trading in the shares is expected to resume following the publication of the results of the Offering.

Intelligent Bio Solutions Partners with Cliantha Research to Conduct Clinical Study as Part of FDA 510(k) Pathway

Retrieved on: 
Wednesday, February 28, 2024
LC-MS/MS, Blood, Marketing, FDA, News, Trial of the century, DSR, Contract research organization, Classification, Intelligence, Partnership, Medical device

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company") (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research , a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company") (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research , a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan.
  • The fingerprint sweat specimen will be screened using INBS’ Intelligent Fingerprinting Drug Screening System comprising the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader and compared to the LC-MS/MS results.
  • The start of the clinical study plan marks an exciting milestone for the Company as it advances on its 510(k) pathway.
  • Harry Simeonidis, President and CEO at Intelligent Bio Solutions, commented, “We are pleased to share news of our partnership with Cliantha and progress on our 510(k) journey.

Seismic extends AI leadership with Winter 2024 Release; New features focus on seamless collaboration, enhanced personalization and increased rep efficiency

Retrieved on: 
Tuesday, February 27, 2024
Marketing, Communications, Technology, Other Technology, Software, Artificial Intelligence, Internet, Cloud, Social media, Human voice, AI, News, System, DSR, Customer, Organization, Meeting, Esophageal varices, Revolut, Voice of the customer, Sales

Seismic , the global leader in enablement, today announced its Winter 2024 Product Release with advancements in generative AI, Seismic for Meetings, and Digital Sales Rooms (DSRs).

Key Points: 
  • Seismic , the global leader in enablement, today announced its Winter 2024 Product Release with advancements in generative AI, Seismic for Meetings, and Digital Sales Rooms (DSRs).
  • In an increasingly competitive market, connecting with buyers quickly, efficiently and with a personalized touch is crucial for go-to-market success.
  • With the help of AI-powered Page Authoring, enablement teams can create highly effective playbooks for product launches, sales plays, and industries in minutes.
  • To learn more about the latest additions to the Seismic Enablement Cloud within the Winter 2024 Release, visit the Seismic Blog and view all recent product news on the Seismic Product Innovation Center .

SEQUANA MEDICAL ANNOUNCES EUR 3.0 MILLION CONVERTIBLE FINANCING FROM MAJOR SHAREHOLDERS AND AGREEMENT WITH LENDERS ON DEFERRAL OF DEBT SERVICE PAYMENTS

Retrieved on: 
Thursday, February 8, 2024
DSMB, AMERICA, Brussels Stock Exchange, Overload, PMA, Patient, US FDA, FDA, Partner, BlackRock, Heart failure, DSR, EUR, CE, Cancer, Liver disease, Pharmaceutical industry

As a result, the Company will significantly reduce its cash burn and halt all European commercial activities whilst maintaining the CE mark.

Key Points: 
  • As a result, the Company will significantly reduce its cash burn and halt all European commercial activities whilst maintaining the CE mark.
  • In addition, the randomized phase of the DSR MOJAVE study will start after alfapump PMA approval.
  • These actions are forecast to significantly reduce the cash requirements through to the end of 2024 by approximately EUR 9.0 million.
  • Through focusing on those activities needed for alfapump FDA approval, we optimize Sequana's ability to deliver on our goals and generate substantial value to all our shareholders.

Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure

Retrieved on: 
Tuesday, January 23, 2024
Patient, DSMB, Overload, Heart failure, Cancer, Data monitoring committee, DSR, Brussels Stock Exchange, Cardiorenal syndrome, Safety, 2.0, Liver disease, Heart, Pharmacotherapy, Furosemide, Fluid, RED, Pharmaceutical industry

After the last DSR treatment, patients will be followed for a three-month safety follow-up period.

Key Points: 
  • After the last DSR treatment, patients will be followed for a three-month safety follow-up period.
  • The first patient is expected to be enrolled in Q1 2024 and interim data are planned for H2 2024.
  • Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “We are delighted to announce the ongoing progress of our US MOJAVE study and look forward to enrol the first patient in the randomized cohort later this quarter.
  • Their diuretic responseiii nearly normalized with a mean increase of 324% in their six-hour urinary sodium excretion post-treatment vs baseline.